Project Engineer / Project Technical Specialist

The Project Engineer / Project Technical Specialist – Radiopharma and Medical Isotopes is responsible for providing technical support and guidance on assigned projects involving the design and development of radiopharmaceutical systems and components, including hot cells, isolators, and integrated accessories. Key responsibilities include design support, preparation of technical documentation, oversight and technical management of subcontractors, design verification, and manufacturing support. The Project Engineer / Technical Specialist works in close collaboration with Project Management, serving as the primary technical point of contact on assigned projects. They are responsible for managing and resolving technical matters with both internal teams and external stakeholders to ensure successful project execution. This role requires a strong foundation in engineering principles and experience in developing and reviewing technical deliverables commonly required in engineering project execution.

Responsibilities:

Development of technical documentation in support of the project(s), including documentation such as:
Design Documentation (design requirements, FMEA’s, design plans, etc.)
Procedures and Instructions (operation manuals, test plans, etc.)
Technical and Vendor Specifications (including SOWs used for subcontracted engineering work)
Support the Project Manager (as required) for all quality, risk and technical scope related to planning, executing, monitoring, and closing activities
Registration of pressure boundary components/systems
Provide technical input to support the preparation of requisitions for subcontracted engineering services, and products
Occasionally act as the technical Lead for customer interface events, as coordinated by the Project Manager
Present technical information to customers or colleagues (ex. Design Reviews)
Provide support for Operations (assembly/fabrication/installation/commissioning, both at Promation and at customer facilities) – including technical coordination of assembly tasks requiring special instructions developed by engineering
Provide input to and support in the management of the ‘Rolling Action Items Log’
Responsible for the compilation of Lessons Learned documentation on an on-going basis
Provide support to the Quality Control team with the management of any unforeseen issues requiring documented change (e.g., NCR’s, Corrective Actions, Concession applications)
Provide support to Health Safety for any safety related project initiatives or needs.
Provide input to the Project Manager for project control, such as:
Estimate to complete (schedule/labour hours/material and consumables costing)
Identification of potential project changes – risks and opportunities for scope/schedule and budget change
Provide technical support for preparation of any required COR.
Support proposal activities such as quotes and COR’s as assigned by the Engineering Manager/Supervisors
Assume additional duties and responsibilities as requested by Management.
Requirements:

A post-secondary degree and/or diploma in industrial or mechanical engineering, or a related field
Minimum 3 years of project engineering experience where production challenges are continuously unique rather than repetitive in nature.
1-2 years of relevant industry experience (Radiopharmaceutical / Nuclear Medicine, Pharmaceutical / Biotech Manufacturing)
Experience with GMP requirements for clean rooms and isolators
Familiarity with regulatory requirements in the pharmaceutical and/or nuclear industries
Experience with Installation Qualification, Operational Qualification, and/or Performance Qualification
Experience with validation testing/protocols in the pharmaceutical industry
Knowledge of pharmaceuticals manufacturing production processes
Preference provided to candidates with experience in the following:
HEPA, ULPA filtration systems
Hot cell and isolator liners and cladding
Structural support frames
Manipulators
Dose calibrators
Radiation shielding of radiopharmaceutical products

We are an Equal Opportunity Employer. We do not discriminate in hiring based on sex, gender identity, sexual orientation, race, colour, religious creed, ethnic origin, disability, or any other characteristic protected by federal, provincial, or local law.

If you require a reasonable accommodation for any part of the employment process, please contact us and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis.


Name *
Email *
Message
Upload your CV here: *
Position:
 
You must create an Indeed account before continuing to the company website to apply Read more