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 fillfinish 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 fillfinish programs. The Principal Process Engineer will guide cross-functional teams mentor engineering staff and ensure the development of highly robust scalable compliant and efficient fillfinish 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 fillfinish 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 fillfinish 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 fillfinish 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 fillfinish 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 fillfinish operations.
• Advise internal leadership and client executives on fillfinish 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 fillfinish operations including aseptic filling formulation sterile filtration lyophilization and automated inspection.
• Extensive experience with automated fillfinish 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 fillfinish programs or manufacturing sites.
• Proven ability to lead cross-functional teams and mentor engineering staff.
• Experience shaping fillfinish 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 fillfinish 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.