Principal Process Engineer

Syner-G • Pleasant Prairie, WI

1d • Remote

About The Position

Syner-G is seeking a Principal Process Engineer with 18+ years of experience to provide strategic technical leadership in the design, optimization, automation, and reliability of complex biomanufacturing processes, with a strong emphasis on fill–finish operations. This role serves as a senior technical authority responsible for shaping long-term sterile manufacturing strategy, leading major engineering and automation initiatives, and driving innovation across multiple client fill–finish programs. The Principal Process Engineer will guide cross-functional teams, mentor engineering staff, and ensure the development of highly robust, scalable, compliant, and efficient fill–finish processes that support development, clinical, and commercial operations.

Requirements

• BS/MS in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field preferred.
• 18+ years of experience in process engineering within biotech, pharmaceutical, or advanced manufacturing environments.
• Significant hands-on experience with fill–finish operations including aseptic filling, formulation, sterile filtration, lyophilization, and automated inspection.
• Extensive experience with automated fill–finish equipment (e.g., vial/syringe filling machines, isolators, RABS, lyophilizers, CIP/SIP systems, formulation skids).
• Deep expertise with automation platforms such as DeltaV, Rockwell, Siemens, and SCADA/PLC systems supporting sterile operations.
• Demonstrated leadership in process development, scale-up, equipment integration, and optimization across multiple fill–finish programs or manufacturing sites.
• Proven ability to lead cross-functional teams and mentor engineering staff.
• Experience shaping fill–finish strategy, sterility assurance approaches, and long-term operational planning.
• Expert-level understanding of aseptic processing, sterile barrier systems, mass/energy balances, process control, and fill–finish equipment design.
• Strong ability to develop, interpret, and approve P&IDs, engineering drawings, automation logic, and lyophilization cycle development documentation.
• Advanced data analysis and modeling capabilities using engineering and statistical tools.
• Excellent communication, leadership, and program management skills.
• Ability to manage multiple high-priority initiatives in a fast-paced, technically demanding environment.

Responsibilities

• Lead large-scale process development, optimization, and scale-up initiatives across aseptic fill–finish operations including formulation, compounding, filtration, vial/syringe filling, lyophilization, and capping.
• Serve as a senior technical authority for sterile process engineering, isolator/RABS technologies, aseptic automation strategies, and integration of advanced fill–finish platforms.
• Develop, review, and approve engineering documentation such as PFDs, P&IDs, formulation schematics, filling line specifications, lyophilizer cycle development studies, and aseptic process descriptions.
• Conduct modeling, statistical analysis, and holistic assessments of filling operations to improve yield, accuracy, sterility assurance, throughput, and long-term system reliability.
• Lead commissioning, qualification, and startup of filling lines, automated inspection systems, lyophilizers, isolators, RABS, formulation skids, and associated utilities.
• Partner with automation, engineering, operations, and quality teams to implement advanced control strategies, environmental monitoring integration, and data-driven fill–finish process improvements.
• Troubleshoot critical issues related to filling performance, weight control, sterility deviations, lyophilizer performance, equipment failures, or automation logic errors, providing expert-level guidance to client stakeholders.
• Lead multi-site technology transfers for fill–finish operations, ensuring process consistency, sterility risk mitigation, and scalability across development, clinical, and commercial sites.
• Manage vendor relationships and oversee specification, customization, and implementation of filling lines, isolators, visual inspection systems, and lyophilization technologies.
• Drive continuous improvement initiatives focused on reducing vial reject rates, optimizing fill accuracy, enhancing aseptic controls, improving cycle times, and enabling robust commercial readiness.
• Mentor, coach, and develop engineering staff at all levels, building organizational expertise in sterile manufacturing and fill–finish operations.
• Advise internal leadership and client executives on fill–finish strategy, lifecycle planning, capacity modeling, and investment decisions.
• Influence enterprise-wide standards for aseptic processing, equipment specifications, sterility assurance, and technology roadmaps.

Benefits

• We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars.
• This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
• Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.”

What This Job Offers

• Job Type: Full-time
• Career Level: Principal