TheProject Engineer/Senior Specialist, Project Engineeringleads the execution of complex engineering projects in a GMP biopharmaceutical environment, exercising independent technical judgment with minimal supervision. Acting as a technical advisor across the project and production teams, the role drives equipment implementation, commissioning and qualification, and production support, while coaching junior engineers and building cross-functional alignment on technical issues.

Job Responsibilities

Project Leadership & Stakeholder Management:

• Lead the execution of complex technical projects, coordinating internal and external stakeholders to ensure alignment, efficiency, and regulatory compliance.
• Support client and stakeholder engagement on project deliverables, providing technical input and responding to queries in coordination with the project manager.
• Coordinate design, construction, and internal teams to execute capital and client projects.
• Track project scope, schedule, and budget for assigned engineering projects; escalate risks and issues to the Engineering Manager in a timely manner.
• Prepare and present project status updates to the Engineering Manager and cross-functional stakeholders.

Engineering Design & Specification:

• Define specifications for in-scope systems and equipment, including user requirement specifications (URS).
• Design and specify equipment for biopharmaceutical manufacturing, including aseptic Fill/Finish operations, bioreactors, chromatography systems, and filtration.
• Support the design and operation of clean utilities, including purified water (PW), water for injection (WFI), compressed air, and clean steam.
• Apply cleanroom design, grade classifications, GMP material/personnel flows, and HVAC design principles to project deliverables.
• Review bids, design documents, quotations, and functional specifications against project requirements, technical specifications, and budget.
• Manage engineering change control for assigned systems; ensure drawings, specifications, and documentation are maintained accurately and in a state of audit readiness.
• Conduct risk assessments (e.g. FMEA, HAZOP) to identify and mitigate technical and compliance risks during design and implementation phases.

Commissioning, Qualification & Compliance:

• Assess process systems and components for compliance with FDA, EMA, HC, and cGMP requirements, including applicable guidelines such as EU GMP Annex 1 and ISPE Baseline Guides.
• Ensure systems meet Environmental Health and Safety (EHS) and regulatory requirements.
• Lead commissioning activities including FAT/SAT execution, punch list resolution, Pre-Start Health and Safety Reviews (PSHSR), and system turnover to end user.
• Provide engineering input and documentation to support IQ/OQ protocol development and execution in collaboration with the Validation team.
• Investigate and resolve deviations from user and system specifications, implementing corrective actions.
• Support manufacturing start-up, including engineering trials, troubleshooting, and technical support to process validation activities.
• Serve as engineering SME during regulatory inspections and internal audits for assigned systems and projects; contribute to inspection readiness activities and responses to observations.

Production & Manufacturing Support:

• Provide technical mentorship to junior engineers and peers, fostering knowledge and capability development within the FME team.
• Collaborate with cross-functional teams including Quality, Validation, Maintenance, and Operations to support site and project objectives.
• Troubleshoot equipment and process issues to minimize downtime and optimize performance; lead root cause investigations and implement corrective and preventive actions.
• Implement process improvements to increase production rates, yields, and uptime.
• Prepare technical reports, risk assessments, and protocols on manufacturing systems and processes.
• Support scale-up through process optimization and validation for large-scale production.
• Develop and review SOPs to standardize practices and maintain regulatory compliance.

Minimum Qualifications:

• Working knowledge of cGMPs and applicable regulatory frameworks (FDA, EMA, Health Canada) in a biopharmaceutical or regulated production environment
• Working knowledge of facilities and equipment design in a GMP environment, including cleanroom layout, HVAC systems, and regulatory compliance
• Experience in a fast-paced, customer-oriented manufacturing or operations environment
• Ability to work independently with minimal guidance in a project environment
• Demonstrated ability to lead and coordinate cross-functional project activities with and without direct authority
• Strong organizational, communication, and technical writing skills, with the ability to work effectively as part of a high-functioning team
• Demonstrated ability to provide technical mentorship and knowledge to transfer to junior engineers and peers

Preferred Qualifications:

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or related field), or equivalent experience; an advanced degree is an asset.
• 5+ years of experience in biopharmaceutical manufacturing, process engineering, or a related technical role.
• Professional Engineering (P.Eng) designation.
• Demonstrated expertise in capital projects, commissioning, qualification, and troubleshooting within a regulated environment.
• Experience with global regulatory bodies (FDA, EMA, HC, PMDA) and cGMP requirements, including familiarity with engineering standards such as ASME BPE and ISPE Guidelines.
• Proficiency in risk assessment methodologies, project execution, and continuous improvement initiatives.
• Experience in fill-finish processes, including aseptic processing, vial filling, and lyophilization.

• Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs.
• Ability to travel domestically and internationally as required for Factory Acceptance Testing (FAT) or other technical activities including supplier and client site visits.
• Physical demands may include standing for extended periods, lifting up to 50lbs, and working in cleanroom environments with appropriate gowning requirements.
• Required to wear Personal Protective Equipment (PPE) including respirators.

The work schedule listed reflects the employees expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.