Principal Process Engineer

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.