Principal Process Engineer

Company: Syner-G BioPharma Group
Location: Pleasant Prairie
Posted on: February 6, 2026

Job Description:

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. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis 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. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: 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. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) 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. QUALIFICATIONS AND REQUIREMENTS: Education BS/MS in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field preferred. Experience 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. Technical Skills 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. ESSENTIAL FUNCTIONS: Physical Demands The employee must be able to use a computer, walk, sit, lift up to 25 pounds, and occasionally stand, stoop, or kneel. Vision requirements include close focus and the ability to adjust focus. Reasonable accommodations may be made for individuals with disabilities. Work Environment The work environment includes office, laboratory, mechanical space, and cleanroom settings with moderate noise levels and controlled environmental conditions. TOTAL REWARDS PROGRAM : 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.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Keywords: Syner-G BioPharma Group, West Allis , Principal Process Engineer, Engineering , Pleasant Prairie, Wisconsin