Process Engineering Manager

Job Description About the role

The Process Engineering Manager serves as a subject matter expert for process unit operations within pharmaceutical manufacturing. This role is responsible for ensuring process equipment is fit for purpose for drug substance and drug product manufacturing while meeting all regulatory, quality, capacity, and EHS requirements. The role leads the full lifecycle management of assigned process systems, including design, installation, qualification, production support, deviation resolution, maintenance, and eventual decommissioning.

This position drives continuous improvement initiatives by overseeing equipment reliability, performance monitoring, and system optimization to reduce downtime and enhance manufacturing throughput. The Process Engineering Manager develops and implements robust engineering solutions to complex technical and operational challenges while providing strong people leadership through hiring, coaching, and developing a high‑performing team of Process Engineers.

• Apply engineering expertise in heat transfer, mass transfer, fluid dynamics, and reaction kinetics to diagnose and resolve complex process engineering challenges
• Provide leadership to Manufacturing and Maintenance teams during troubleshooting and issue resolution on the production floor
• Serve as system owner and lead continuous improvement initiatives using tools such as DMAIC, FMEA, and RCA
• Identify, design, and implement improvements that enhance equipment performance, reliability, and operational efficiency
• Monitor departmental metrics and present performance updates to site leadership
• Respond with urgency to equipment issues impacting manufacturing continuity or product quality

• Partner cross‑functionally with Manufacturing, Manufacturing Sciences, and Pharmaceutical Sciences to align on technology needs and readiness
• Lead evaluation and selection of advanced process equipment and qualified vendors
• Identify emerging industry trends and define long‑term strategies for process equipment and technology adoption
• Develop CAPEX business cases, including total cost of ownership and ROI analyses
• Manage process equipment vendors and engineering partners to deliver CAPEX and OPEX projects

• Lead or support feasibility assessments and full lifecycle implementation of process and equipment engineering projects
• Ensure accurate and complete delivery of project turnover packages, including as‑built drawings, maintenance documentation, and spare parts data
• Develop system user requirements, classifications, technical specifications, and scopes of work
• Create RFx packages for vendors, consultants, commissioning agents, and contractors
• Support commissioning activities including FAT and SAT
• Support qualification and validation activities for process equipment
• Conduct design reviews with Quality, Manufacturing, Utilities, Maintenance, Reliability, Calibration, and Automation stakeholders

• Lead process hazard analyses (e.g., HAZOP) for hazardous manufacturing processes
• Incorporate risk‑reduction strategies into equipment and control system designs
• Conduct EHS‑focused design reviews to improve process and equipment safety
• Lead investigations related to process equipment performance and implement effective CAPAs

• Develop and support process material balances
• Build and utilize process unit operation capacity models to identify bottlenecks and constraints
• Mentor others in capacity modeling and support GMP manufacturing and utility planning decisions

• Provide technical expertise and documentation support during internal and regulatory audits and inspections
• Ensure operational readiness for assigned systems and equipment

• Bachelor’s or Master’s degree in Engineering or a related scientific discipline
• 7+ years of engineering or related experience with increasing responsibility
• 5+ years supporting pharmaceutical or biotechnology regulated manufacturing…