Principal Process Engineer

Pleasant Prairie, Wisconsin, United States

COMPANY

DESCRIPTION:

A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization.

It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Syner-G was honored with Bio Space’s Best Places to Work award, reflecting our commitment to fostering a positive and engaging work environment focused on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

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.

Travel to client sites may be required up to 100%, based on project demands and client expectations.

• 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…