Job Title: Manufacturing Process Engineer

Job Description

The Manufacturing Process Engineer supports the development, implementation, and optimization of manufacturing processes in a highly regulated environment. This role works closely with Manufacturing, Quality, Regulatory, and Operations teams to ensure that processes are safe, compliant, efficient, and production-ready, contributing directly to the advancement of nuclear medicine and the improvement of patient outcomes.

Responsibilities

- Develop, implement, and continuously improve manufacturing processes and production workflows to enhance safety, quality, and efficiency.
- Collaborate closely with Manufacturing, Quality, Regulatory, and Operations teams to define process and equipment requirements that meet technical and regulatory standards.
- Lead process development initiatives, including process validation and continuous improvement projects, to support reliable and scalable production.
- Create, update, and maintain engineering documentation such as drawings, bills of materials (BOMs), process specifications, and detailed work instructions.
- Perform Process Failure Mode and Effects Analysis (PFMEA) and support risk assessments to identify, evaluate, and mitigate manufacturing risks.
- Troubleshoot manufacturing issues related to tooling, fixtures, equipment, and mechanical processes, implementing corrective and preventive actions.
- Support equipment installation, commissioning, qualification, and optimization to ensure robust and compliant operation.
- Ensure compliance with quality systems, regulatory requirements, Good Manufacturing Practice (GMP) standards, and engineering safety principles.




- Participate in root cause investigations and lead or support corrective actions and process improvement efforts to prevent recurrence of issues.
- Partner with quality and regulatory teams to maintain documentation and processes that meet audit, inspection, and regulatory expectations.
- Contribute engineering expertise to cross-functional project teams focused on advancing nuclear medicine technologies and healthcare solutions.

Essential Skills

- At least 5 years of mechanical manufacturing or process engineering experience in a production environment.
- Proven experience working in a highly regulated environment, with a robust preference for medical or pharmaceutical manufacturing.
- Hands-on experience with process validation, including planning, execution, documentation, and analysis of validation activities.
- Demonstrated ability to troubleshoot manufacturing processes, equipment, tooling, and fixtures, and implement effective solutions.
- Experience leading or participating in continuous improvement initiatives using methodologies such as Lean and Six Sigma.
- Practical experience conducting PFMEA and formal risk assessments for manufacturing processes and equipment.
- Strong understanding of quality systems, GMP requirements, and regulatory compliance in a manufacturing setting.




- Knowledge of engineering safety principles and their application in process and equipment design and operation.
- Experience creating and maintaining manufacturing documentation, including work instructions, drawings, process specifications, and BOMs.
- Ability to collaborate effectively with cross-functional teams including Manufacturing, Quality, Regulatory, and Operations.

Additional Skills & Qualifications

- Experience in pharmaceutical or medical device manufacturing environments.
- Familiarity with nuclear medicine or other specialized healthcare manufacturing fields.
- Exposure to Lean Six Sigma tools and methodologies to drive process efficiency and waste reduction.
- Strong documentation skills with attention to detail and accuracy in technical records.
- Ability to contribute to long-term, multi-year projects and adapt to evolving technical and regulatory requirements.
- Interest in advancing healthcare and contributing to meaningful innovation in a growing and highly specialized industry.

Job Type & Location

This is a Contract position based out of Ottawa, ON.

Pay And Benefits

The pay range for this position is $50.00 - $65.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Job Type & Location

This is a Contract position based out of Ottawa, ON.

Workplace Type

This is a fully onsite position in Ottawa,ON.

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📌 Manufacturing Process Engineer (Ottawa)
🏢 Actalent
📍 Ottawa