Senior Process Engineer (Sterile & High-Purity Process Systems)
Location: Toronto, ON (Onsite)
Industries: Biopharma
Full-Time | Engineering Design & CQV
We seek a Senior Process Engineer to lead high-impact projects across the bio-pharmaceutical, personal care, and food sectors.
What You'll Do:As a technical leader, you'll deliver end-to-end solutions for integrated process equipment and unit operations in GMP environments, from early design through CQV.
Key Responsibilities:- Lead conceptual, preliminary, and detailed process designs
- Develop deliverables such as:
- Feasibility studies, mass balances, and utility sizing
- Process simulations, PFDs, P&IDs, control strategies
- URS, FDS, equipment specs, cost estimates
- Bid packages, commissioning and qualification protocols
- Guide projects from front-end engineering through start-up and CQV
- Oversee equipment and utility design (e.g., fermenters, TFF, CIP systems)
- Collaborate with controls, validation, and QA teams
- Mentor junior engineers and support proposal development
- Maintain strong client relationships and lead multi-functional teams
- 8+ years in GMP process engineering, ideally with skidded systems
- Experience in process equipment and piping system design
- Commissioning & qualification experience (automated systems preferred)
- Familiarity with CAD, process control, and validation coordination
- Strong communication, organization, and leadership skills
- Comfortable in a fast-paced, multi-project environment
This role offers true engineering creativity with exposure to various exciting, complex projects in a collaborative and technical environment.
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