Syner-G · 22 hours ago
Principal Process Engineer
Pleasant Prairie, WI
Full-time
Onsite
Lead/Staff
18+ years expSyner-G is a company dedicated to enhancing the quality of life through innovative biopharma solutions. They are seeking a Principal Process Engineer to provide strategic technical leadership in biomanufacturing processes, focusing on fill–finish operations, while mentoring teams and driving innovation across various programs.
Health CareManufacturingPharmaceutical
No H1B
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
Qualification
Required
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
Benefits
Market competitive base salary and annual incentive plan
Robust benefit offerings
Generous flexible paid time off program
Company-paid holidays
Flexible working hours
Fully remote work options for most positions
Ability to work “almost anywhere”
Company
Syner-G
Syner-G is a Strategic Development & Delivery Partner™ to biopharma innovators.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Ron Kraus
Chief Executive Officer
Prabu Nambiar
Founder, Board Member
Recent News
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