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Heavy Equipment Operator (Temporary)
Fixed term/Temporary
Canada / Saskatchewan
Published on 3/24/2025
Job reference : 2025-19689
Reporting to the Services Supervisor, this position is responsible for the following duties:
Responsibilities include:
· Responsible for the safe and proficient operation of equipment associated with maintaining site services and miscellaneous earth-moving projects
· Operating various heavy duty equipment for earth-moving projects including haul truck, loader, excavator, and dozer
· Operating various light and medium duty equipment in the performance of general site services duties including gravel truck, vacuum truck, water truck, backhoe, bobcat, semi-tractor, forklift, grader, and bus
· Performing manual labour to support operations and maintenance activities, such as clean-up, hauling and stacking materials, and assisting skilled or semi-skilled crafts in the performance of their tasks
· Other duties and assignments as required by the Department and assigned by the Services Supervisor
· Embrace and support Operational Excellence efforts and OE Culture
· Comply with all Orano health, safety and environmental policies, practices and procedures
· Promote and adhere to Orano Canada’s values: Customer Satisfaction, Continuous Improvement, Respect and People Development, Cohesion and Team Spirit, and Exemplarity, Integrity, Responsibility
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Mine Technologist - 4 Positions
Regular/Permanent
Canada / Saskatchewan
Published on 3/13/2025
Job reference : 2025-18913
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy! As we expand our team and take on exciting new projects in Saskatchewan’s North, we invite you to be a part of our team!
In this role, you will have the opportunity to operate a variety of data logging equipment such as deviation, gamma, downhole camera, and sonar, while analyzing mining data, The position involves performing quality checks on data, collecting composite ore samples, and maintaining the solids separation and uranium mass flow devices. You will be responsible for conducting QA tests, solving analysitcial problems, and ensuring safety procedures are followed. Additionally, you’ll assist with equipment location, create reports, manage inventory, and contribute to tool improvements. If you’re excited about this opportunity, we encourage you to apply!
Responsibilities include:
· Analyse the cavity dimensional feedback data and upload the jet nozzle dynamic mining plan in the mining system
· Operate all electrical logging equipment including deviation, gamma, downhole camera and sonar tools, and perform quality checks on equipment and the data gathered
· Collect and record composite samples of ore production during mining and drilling
· Ensure proper operation of the solids separation system & Uranium Mass Flow device
· Ensure mining pipes are properly tracked in manual and electronic systems, and conduct QA tests prior to mining use
· Follow safe operating procedures & work instructions and complete required forms for record keeping
· Ensure drilling & mining techniques utilized are properly documented
· Collect records from the work site (Orano and contractor’s forms/daily logs)
· Create daily reports, updates and recommendations
· Create purchase requisitions for parts required and track inventory of parts
· Assist with mine equipment relocation and operation
· Involved with compositing the results of the field program in a technical report
· Involved in tools improvement by proposing and suggesting modifications based on field results
Work Location & Schedule:
· McClean Lake Mine Site
· 14 days in and 14 days out rotating schedule, although adjustment of schedule may be required from time to time
· Normally an 11 hour work day, although some activity outside or normal working hours may be required
Pick-Up Points: Saskatoon, Prince Albert, La Ronge, Buffalo Narrows and the designated communities in the Athabasca region of Uranium City, Stony Rapids, Fond du Lac, and Wollaston.
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Principal Nuclear Safety Consultant
Regular/Permanent
United Kingdom / North West / Cheshire
Published on 3/21/2025
Job reference : 2025-19639
Within the Nuclear Safety discipline of Orano Limited, you will deliver technically competent documents striving to exceed client requirements, by working independently as well as supporting experienced safety consultants.
You will support our clients as part of an Orano team in projects of new build, decommissioning or ongoing operational facilities in providing safety cases and associated assessments. To ensure work is delivered to a high standard, timely and to the programme agreed. As projects progress, or new ones become available, you will have the opportunity to develop new skills and to support, mentor graduate consultants within the business.
Role and responsibilities
The Nuclear Safety & Technical / Project Lead will deliver complex nuclear safety cases, with experience of the full lifecycle of facilities, to a variety of clients.
Responsibilities will include:
Developing and presenting robust and reasoned arguments in a rational and coherent manner
Delivering consultancy that meets, and exceeds the expectations of the client, in regard to technical excellence and the quality of deliverables
Delivering consultancy that meets, and exceeds the expectations of the client, in terms of timescales and cost, in a way that supports the long-term growth of the business and its reputation
Managing this work (in the form of small to medium sized projects) either as a project or technical lead
Delivering the work within budget and to the agreed programme whilst keeping track of the project (all aspects)
Liaising with all concerned of both technical and commercial progress
Developing skills in growing projects
Identifying opportunities with clients and supporting, mentoring, coaching and helping others to develop within the business
This role can be based at our Warrington or Abingdon office.
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Senior Nuclear Safety Consultant
Regular/Permanent
United Kingdom / North West / Cheshire
Published on 3/21/2025
Job reference : 2025-19638
Within the Nuclear Safety discipline of Orano Limited, you will deliver technically competent documents striving to exceed client requirements, by working independently as well as supporting experienced nuclear safety consultants.
You will support our clients as part of an Orano team in projects of new build, decommissioning or ongoing operational facilities in providing nuclear safety cases and associated assessments. To ensure work is delivered to a high standard, timely and to the programme agreed. As projects progress, or new ones become available, you will have the opportunity to develop new skills and to support, mentor graduate consultants within the business.
Role and Responsibilities
As a Nuclear Safety Consultant at Orano Limited, you will be involved in a variety of specialist tasks. This could include:
Delivering consultancy that meets, and exceeds the expectations of the client, in regard to technical excellence, the quality of deliverables, timescales and cost, in a way that supports the long-term growth of the business and its reputation.
Working as the technical lead for safety in multi discipline projects
Actively participating in the integrated design process and interfacing with engineers and human factors specialists.
Developing and present robust and reasoned arguments in a rational and coherent manner.
Represent the Company on technical matters to clients/external stakeholders.
Provide technical checking & verification for technical / compliance / thoroughness of argument / QA standards.
Liaising with all concerned on technical progress.
Identifying opportunities with clients and supporting, mentoring, coaching and helping others to develop within the business.
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Summer Student, Management Systems
Fixed term/Temporary
Canada / Saskatchewan
Published on 2/12/2025
Job reference : 2025-19026
*Must be a resident of the Athabasca Basin
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy! Our McClean Lake mill is the most technologically advanced mill in the world for the processing of high-grade uranium ore without dilution.
Responsibilities:
· Assist with ensuring that the Integrated Management System (IMS) is maintained and improved in accordance with regulatory requirements, the ISO 14001/45001 standards, corporate requirements, and the needs of the McClean Lake Operation
· Administration and control of approved IMS Documents
· Assist/participate in internal audit process
· Publish IMS Documents and maintain the document control system
· Maintain regulatory records
· Maintain the regulatory library
· Track internal actions
· Track regulatory commitments and obligations
· Assist in the management of the non-conformance investigation and follow-up process
· Participate in internal audits on the IMS and ensure that it is subject to management review
· Assist in the preparation of the licensing and permitting applications
· Any other duties assigned by the supervisors
Work Location & Schedule:
· McClean Lake
· 14 day in/ 14 day out rotating schedule; May to August 2025. Fridays are fly days.
· Normally an 11 hour work day, although some activity outside of normal working hours may be required
Pick-Up Points: Saskatoon, Prince Albert, La Ronge, Buffalo Narrows and the designated communities in the Athabasca region of Uranium City, Stony Rapids, Fond du Lac, and Wollaston.
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Summer Student, Services
Fixed term/Temporary
Canada / Saskatchewan
Published on 3/21/2025
Job reference : 2025-18946
*Must be a resident of the Athabasca Basin
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy! Our McClean Lake mill is the most technologically advanced mill in the world for the processing of high-grade uranium ore without dilution.
If you’re excited about the opportunity to work at a northern mine site, we encourage you to apply!
Responsibilities include:
· Perform all duties required, in a safe and efficient manner
· Successfully complete training in the following areas: confined space entry, fall protection, lockout, WHIMIS, radiation
· Actively participate in weekly safety huddles
· Main responsibilities will involve providing labor support for miscellaneous projects as assigned (painting, shoveling, washing equipment)
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Summer Student, Radiation Protection
Fixed term/Temporary
Canada / Saskatchewan
Published on 3/21/2025
Job reference : 2025-18939
*Must be a resident of the Athabasca Basin
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy! Our McClean Lake mill is the most technologically advanced mill in the world for the processing of high-grade uranium ore without dilution.
If you’re excited about the opportunity to work at a northern mine site, we encourage you to apply!
Responsibilities include:
Carry out all measurements prescribed in procedures and work instructions
· Record data collected as prescribed
· Input data into appropriate databases or other records
· Wash and assemble radiation protection equipment (Respirators, Motor units, etc.)
· Carry out all prescribed area, point and personnel monitoring and develop required records
· Perform (or arrange for the performance of) calibration and maintenance of measuring devices and systems as prescribed
· Liaise with supervisors and workers in all departments to ensure that actions in response to operational conditions are carried out as required
· Provide assistance and advice to employees on radiation and radiation protection related matters
· Understand the three basic principles of the environmental policy – comply with legislation, protect the environment and continually improve
· Understand, and work to minimize, the impact of their work on the environment
· Follow Procedure 715, Spill Response, by reporting any spill discovered to their Supervisor
· Follow Procedure 712, Waste Management, by segregating wastes appropriately
· Support the Environment Group in the designation of radioactive materials for the waste management program
· Comply with the Saskatchewan Occupational Health and Safety Act and Regulations, company health and safety policies, practices, and procedures, which apply to their work
· Apply the Internal Responsibility System (Procedure 791) which includes the Pathway to Safety program
· Immediately report any unsafe conditions or work practices to their supervisor
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Summer Student, Metallurgical Laboratory
Fixed term/Temporary
Canada / Saskatchewan
Published on 3/21/2025
Job reference : 2025-18925
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy! Our McClean Lake mill is the most technologically advanced mill in the world for the processing of high-grade uranium ore without dilution. As a metallurgical laboratory summer student, you’ll have the opportunity to gain some hands-on experience with chemicals, reagents, daily checks and following proper safety procedures. We look forward to reviewing your application!
Responsibilities include:
· Comply with the Saskatchewan Occupational Health and Safety Act and Regulations, WHIMIS, company health and safety policies, practices, and procedures
· Handling of chemicals and reagents
· Operation of technical instruments and meters. Daily checks and calibrations
· Carry out chemical analysis measurements using published work instructions
· Record data collected as prescribed
· Input data into appropriate databases or other records
· Stock, replenish, laboratory supplies as needed
· Alerts metallurgy supervision of any irregularities which may have an effect on analytical accuracy, sample throughput, and instrument operation
· Carries out other procedures and assignments as required with supervision
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Journeyperson Heavy Duty Mechanic (Temporary)
Fixed term/Temporary
Canada / Saskatchewan
Published on 2/19/2025
Job reference : 2025-19116
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy! As we expand our team and take on exciting new projects in Saskatchewan’s North, we invite you to be a part of our team!
As a key player of the Mine Maintenance team, you’ll keep our heavy mobile equipment operating at its best. You will troubleshoot complex systems and carry out essential maintenance on a wide array of machinery. If you are ready for a challenge, we invite you to apply!
Responsibilities include:
· Maintenance of heavy mobile equipment including haul trucks, loaders, crawler tractors, graders and excavators
· Periodic maintenance of medium duty mobile equipment as required which may include semi tractors, trailer units, man-lifts, skid steers and buses.
· Maintenance of some stationary equipment including generators and fire pumps
· Use of diagnostic equipment and computerized software that includes, but is not limited to: Cat ET, SIS, Cummins INSITE, and Wabco Toolbox
Efforts and Demands:
· Work in a shop environment
· Work with minimal supervision and often working alone
· Must have full line of good quality personal hand tools
· Perform duties conscientiously and ensure compliance with all health and safety standards
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Journeyperson Industrial Mechanic - Temporary
Fixed term/Temporary
Canada / Saskatchewan
Published on 2/21/2025
Job reference : 2025-18670
Responsibilities include:
· Responsible for all aspects of millwright maintenance in the milling complex and surrounding areas. This may include preventative maintenance work, equipment repairs and participation in developing maintenance programs.
· Rebuilding pumps of various types and sizes
· Removal of pumps, fans and agitators for maintenance
· Bearing replacements, belt/sheave changes and adjustments
· Oil Changes on equipment
· Some occasional welding/fabricating
· Maintain a safe and organized working environment
· Embrace and support Operational Excellence efforts and OE Culture
· Complies with all Orano health, safety and environmental policies, practices and procedures
· Promote and adhere to Orano Canada’s values: Customer Satisfaction, Continuous Improvement, Respect and People Development, Cohesion and Team Spirit, and Exemplarity, Integrity, Responsibility
Work Location & Schedule:
· McClean Lake
· 14 day in/ 14 day out rotating schedule
· Normally an 11 hour work day, although some activity outside of normal working hours may be required
· This position requires moderate physical ability
Fly Day- This position will fly in and fly out on Wednesday
Pick-Up Points: Saskatoon, Prince Albert, La Ronge, Buffalo Narrows and the designated communities in the Athabasca region of Uranium City, Stony Rapids, Fond du Lac, and Wollaston.
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Waste Management Consultant
Regular/Permanent
United Kingdom / North West / Cheshire
Published on 1/14/2025
Job reference : 2024-18063
We are recruiting for a Waste Management Consultant to join our growing and prosperous Waste management team. You will focus on the development and assessment of radioactive waste inventories and characterisation data to support waste management strategies. You will also provide support to other projects in the areas of decommissioning and environmental management.
You will have excellent opportunities to drive your own progression in areas of technical, management and business development capabilities whilst broadening the wider interests of our company.
Responsibilities will include:
Contributing to business development by supporting proposals/bids, supporting waste discipline and implementing improvement initiatives.
Undertaking activities in support of continuous professional development.
Contributing to developing creative ideas, strategies and new service offers which aim to better manage waste to UK and international Clients.
Carrying out studies, research and analysis relating to waste management and Characterisation.
Providing robust and timely technical radioactive waste management expertise to support a range of clients in new build, operations and decommissioning.
Advising on some of the following areas: characterisation (including sentencing), management, production, treatment, storage, packaging and consignment of radioactive waste.
Working with our other departments, such as safety case, decommissioning and engineering to provide our clients with a comprehensive offering.
Producing technical reports for example: Waste Strategies, Project Waste Management Plans, BAT studies, optioneerings, Characterisation strategies, Sampling Plans utilising DQO, packaging proposals, calculations associated with waste activity assessment or dose assessment, generation or application of fingerprints.
Supporting and mentor junior colleagues.
Location: This role can be based at our Westlakes or Warrington office.
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Journeyperson Heavy Duty Mechanic - Services
Regular/Permanent
Canada / Saskatchewan
Published on 3/18/2025
Job reference : 2025-19595
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy!
As a key player of the Site Services team, you’ll keep our heavy mobile equipment operating at its best. You will troubleshoot complex systems and carry out essential maintenance on a wide array of machinery. If you are ready for a challenge, we invite you to apply!
Responsibilities include:
· Maintenance of heavy mobile equipment including haul trucks, loaders, crawler tractors, graders and excavators
· Periodic maintenance of medium duty mobile equipment as required which may include semi tractors, trailer units, man-lifts, skid steers and buses.
· Maintenance of some stationary equipment including generators and fire pumps
· Troubleshoot and repair electrical, mechanical, pneumatic and hydraulic systems
· Use of diagnostic equipment and computerized software that includes, but is not limited to: Cat ET, SIS, Cummins INSITE, and Wabco Toolbox
Efforts and Demands:
· Work in a shop environment
· Work with minimal supervision and often working alone
· Must have full line of good quality personal hand tools
· Perform duties conscientiously and ensure compliance with all health and safety standards
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Mill Maintenance Scheduler
Regular/Permanent
Canada / Saskatchewan
Published on 3/18/2025
Job reference : 2025-19594
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy!
As a key member of the Mill maintenance team, you’ll work closely with supervisors to schedule and prioritize daily tasks. With your attention to detail, you’ll make sure materials are readily available and well-organized for the team. You’ll take the lead in preparing packages for each tradesperson and coordinating the necessary equipment. You’ll also collaborate on planning and assessing mill maintenance, tackling challenges with a technical eye. If you’re ready to take on a new challenge, we encourage you to apply!
Reporting to the Mill Maintenance General Supervisor, this position is responsible for the following duties:
Responsibilities include:
· Work closely with the Maintenance Supervisors to ensure that priority work and accurate work load is scheduled for the following day
· Ensure required materials are accurate and available by performing a physical inspection, and when practical, gathering and kitting material
· Ensure that scheduled work can be completed through consideration of all requirements, such as scaffolding, crane, and other equipment needs, etc.
· Organize and prepare work packages for each tradesperson, including work orders and their scheduled tasks, and given to the supervisor by the end of the current work day
· Become familiar with and organize direct charge materials and parts located in the storage areas
· Assist in planning as required
· Ensure that all data collection equipment, techniques, and procedures are accurate
· Assess mill maintenance from a technical viewpoint, report mechanical deficiencies to mill maintenance senior supervision and provide suggestions for further rectification
· Organize and conduct plant investigations to evaluate or improve plant maintenance
· Compile reports on work as required
· Ensure that all quality and agency compliance standards are met
· Comply with all of Orano Canada’s health, safety and environmental policies, practices and procedures
· Embrace and support Operational Excellence efforts and OE Culture
· Promote and adhere to Orano Canada’s values: Customer Satisfaction, Continuous Improvement, Respect and People Development, Cohesion and Team Spirit, and Exemplarity, Integrity, Responsibility
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Systems Engineering Assistant Intern
Regular/Permanent
USA / Maryland
Published on 3/18/2025
Job reference : 2025-19257
Join our team at Orano USA and contribute to building the clean energy world of tomorrow. As an intern, you'll be part of a leading international player in the nuclear industry, gaining valuable experience in cutting-edge technologies and innovative solutions across the entire fuel cycle.
Under guidance from experienced professionals, the Systems Engineering Intern will assist in various aspects of complex engineering tasks. You'll support systems engineering activities, including safety, security, cybersecurity, and reliability requirements. This internship offers exposure to multidisciplinary teams (chemical, structural/civil, mechanical, I&C, electrical, HVAC) and provides insight into major projects in the nuclear industry.
Objectives:
Assist in coordinating engineering work, including helping to establish and maintain requirements, overall technical solutions, and safety basis documentation.
Support functional analysis and learn to document the functional allocation to systems and subsystems.
Help in identifying and documenting system interfaces, gaining understanding of their importance in complex projects.
Observe and participate in day-to-day operations, interacting with engineers, designers, and engineering technicians on specific project assignments.
Learn about project management by supporting schedule and cost performance tracking, assisting in status report preparation, and observing how deviations are identified and recovery plans proposed.
Engage in various tasks supporting planning, design, procurement, construction, commissioning, and plant operation and maintenance, as appropriate for an internship role.
This internship offers a unique opportunity to gain hands-on experience in the nuclear industry while developing valuable skills in systems engineering and project management.
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Mill Maintenance Planner Pipefitter
Regular/Permanent
Canada / Saskatchewan
Published on 3/18/2025
Job reference : 2025-19593
Orano Canada is a leading producer of uranium in Canada, working to power the future with clean energy!
Join our team and take on a key role at the heart of planning and scheduling maintenance repairs, troubleshooting equipment issues, and implementing innovative solutions. This hands-on position offers the chance to supervise contractors, identify cost-saving opportunities, and contribute to our focus on Operational Excellence. If you’re ready to take on a new challenge, we encourage you to apply!
Responsibilities include:
· Plan and schedule current and future maintenance repairs
· Work closely with maintenance personnel, examining equipment failure and identify root causes. Implement corrective actions to prevent equipment failure reoccurrence
· Ensure maintenance activities comply with regulating authorities
· Responsible for compiling equipment data sheets and specifying material requirements
· Identify resources (equipment, components, personnel, drawings, etc.) required to complete a job, and ensure the availability of resources prior to scheduling
· Update equipment bill of materials as required
· Evaluate trends and identify cost saving opportunities through equipment modifications, material substitutions, etc
· Ensure that the library is accurate and up to date, this includes drawings, WO history, Bill of Material, and Vendor data
· Contractor supervision
· Comply with all of Orano Canada’s health, safety and environmental policies, practices and procedures
· Embrace and support Operational Excellence efforts and OE Culture
· Promote and adhere to Orano Canada’s values: Customer Satisfaction, Continuous Improvement, Respect and People Development, Cohesion and Team Spirit, and Exemplarity, Integrity, Responsibility
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Project Manager
Regular/Permanent
United Kingdom / North West / Cheshire
Published on 3/18/2025
Job reference : 2025-18862
As a Project Manager, you’ll ensure an effective project delivery, striving to achieve established goals and objectives to time, cost and quality. You will be undertaken by a SQEP resource allowing a single point of management contact with customer.
Responsibilities will include:
Ensuring the successful delivery of a Portfolio of projects of varying value and complexity
Ensuring successful financial performance and risk management
Managing/Supporting Customer/Stakeholder group through reviews and progress meetings
Managing negotiations with Customer/Stakeholder/Sub-Contractor
Driving efficiency and best practice, aligning local processes and procedures as applicable
Identifying issues, concerns that either have the potential or will impact the project baseline, and implementing effective risk mitigation strategies
Location: This role can be based at our Westlakes or Warrington office.
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Assistant General Counsel
Regular/Permanent
USA / Maryland
Published on 3/13/2025
Job reference : 2025-18920
Join Orano – Shaping a Sustainable Future Together
About the Role
We're seeking a detail-oriented Assistant General Counsel with 2-4 years of experience to join our legal and compliance team.
This role combines traditional legal work with substantial compliance responsibilities, making it ideal for someone who enjoys both enforcing regulatory frameworks and handling complex legal matters.
Core Responsibilities
Legal:
Drive consistent contracting practices across the organization
Provide strategic legal counsel on commercial agreements and regulatory matters
Review and negotiate terms and conditions for proposals, sales contracts, and government contracts
Partner with cross-functional teams on joint ventures and agreements
Support litigation management when needed
Compliance:
Develop, implement, and maintain company compliance policies and procedures
Design and conduct employee compliance training programs
Monitor adherence to internal policies and regulatory requirements
Support the Chief Compliance Officer in preparing compliance reports and audit responses
Lead internal compliance assessments and coordinate responses to external audits
Create and maintain compliance documentation and tracking systems
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Senior Clinical Project Manager
Regular/Permanent
USA
Published on 1/6/2025
Job reference : 2025-18623
Orano Med:
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
Position Summary:
The Senior Clinical Project Manager is responsible for project management and oversight of assigned clinical trials.
Position Responsibilities:
Oversight checks including monitoring report review and TMF checks.
Status meeting attendance, meeting minute review/taking.
Invoice review, confirmation of services received.
Support CRO with site level issues including non-compliance, etc.
Review data cleaning metrics, address backlogs.
Review or create/amend study level documents including ICFs, protocols, study plans, training materials, etc.
Provide study status updates.
Manage study to budget and timelines.
Other duties as assigned.
***Will be a remote position***
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Senior Manager, Data Management
Regular/Permanent
USA
Published on 8/6/2024
Job reference : 2024-17473
Position Summary:
This role will be responsible for oversight of outsourced data management activities and be charged with developing data management oversight and data cleaning processes and a CRF library.
Major Duties and Responsibilities:
Oversee outsourced data management activities by ensuring the design, development and maintenance of clinical databases meets regulatory requirements and industry standards and developing and monitoring key performance indicators (KPIs) for data management service providers.
Ensure timely and appropriate reconciliation of external data sources against clinical databases on assigned studies.
Collaborate with cross-functional teams including Clinical Operations, Biostatistics and Clinical Development to ensure high quality and on time delivery of study level data.
Collaborate with internal stake holders to develop an internal data review process.
Manage internal data review process and issuing / resolution of queries.
Develop global CRF library for re-use on future studies to improve study database build timelines.
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Instrumentation Specialist, CQV
Regular/Permanent
USA / Indiana
Published on 1/17/2025
Job reference : 2024-16084
Orano Med:
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
Job Summary:
Orano Med is seeking an Instrumentation Specialist, CQV or Sr. Instrumentation Specialist, CVQ for ATLab Indianapolis, a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability.
Job Responsibilities:
Oversee IQ/OQ/PQ for new instruments
Draft/review/approve documents related to CQV (SOPs, calibration certificates, IQ/OQ/PQ protocols, completed IQ/OQ/PQ reports)
Equipment/service logs: establish, review, maintain
URS for equipment: Assist with drafting/review/approval
Responsible for a variety of cGMP and non-cGMP instruments including:Production: preparatory LC, fluid transfer, dispensing, weighing, EM
QC: LC, HPGe, gamma counter, sterility, analytical balances, pipettes
Hot cells: VPHP, EM, fill/finish, other sensors/controls
Safety: radiation detectors for personnel, surfaces, air
General: refrigerators/freezers, incubators
Assist with cGMP aspects of facilities equipment/sensors/controls: hot cells/cleanrooms/HVAC, temperature/RH, particle counters, fume hoods, access control, etc.
Work with instrument operators to develop robust protocols for system suitability checks for equipment
Assist with vendor qualifications
Top Priority: On-Time Production/Release of Product Batch Release
All tasks from the Setup Phase that continue into Production Phase.
Carrying out/supervising calibration procedures and equipment maintenance to ensure that instruments maintain their qualified status.
Preparation of calibration certificates and data reports using appropriate Quality documentation.
Ensuring that the equipment is calibrated as per specifications and industry standards.
Oversee warranties, PMs, scheduled recalibration/requalification
Scheduling appointments for equipment maintenance and servicing.
Troubleshooting and repairing equipment and/or supervise outside contractors performing these tasks
Testing repaired equipment to verify qualified status
Ensuring a complete stock of backup instruments, spare parts, calibration equipment, other supplies.
Expert on instrumentation: liaison to management/inspectors
Write protocols for in-house calibrations/qualifications
Analyze/suggest equipment upgrades and software
Study industry guidelines and perform Change Controls to bring Orano Med SOPs into alignment (FDA, USP/EP, ICH, PDA, etc.)
Oversee investigations to resolve deviations/OOS/recalls/complaints/FMEAs related to equipment.