Sr. Process Engineer

Sr. Process Engineer

Bedford, Massachusetts, United States

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. To learn more about who we are and what drives us, watch our company video here.

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 Bio Space'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.

POSITION OVERVIEW:

Syner-G is seeking a Senior Process Engineer with 10+ years of experience supporting the design, installation, commissioning, qualification, startup, and operational readiness of pharmaceutical manufacturing systems within GMP-regulated environments. This role will serve as a technical lead for lyophilization (freeze-drying) systems supporting sterile injectable and aseptic vial manufacturing operations.

The ideal candidate will possess extensive experience integrating lyophilizers with aseptic filling lines, automation platforms, and manufacturing systems while providing technical oversight throughout the project lifecycle, including facility design, equipment specification, procurement, installation, commissioning, qualification, startup, performance verification, and commercial operation. This individual will collaborate closely with engineering, automation, validation, manufacturing, quality, and equipment vendors to ensure successful project delivery while maintaining compliance with GMP requirements and regulatory expectations.

The Senior Process Engineer will provide leadership in process engineering, system integration, equipment startup, troubleshooting, and operational readiness activities while supporting continuous improvement and technology transfer initiatives across client programs.

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 the design, installation, commissioning, qualification, startup, and operational readiness of pharmaceutical lyophilization systems supporting sterile vial manufacturing operations.
• Serve as the technical lead for lyophilizer integration within aseptic filling and finishing facilities, ensuring alignment between upstream and downstream manufacturing processes.
• Provide technical leadership during facility design, equipment specification development, User Requirements Specification (URS) creation, design reviews, and equipment procurement activities.
• Review and support development of engineering deliverables including process flow diagrams (PFDs), P&IDs, process descriptions, functional specifications, equipment specifications, and engineering studies.
• Lead and support Factory Acceptance Tests (FATs),…