Sr. Process Engineer

Job DescriptionJob 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. 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 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 Sr. Process Engineer with 7–11 years of experience to lead the design, optimization, and automation of manufacturing and laboratory processes. This role will serve as a primary Subject Matter Expert (SME) for key cell therapy unit operations and will guide process monitoring, improvement initiatives, technical investigations, and technical transfers within cGMP environments. The Senior Process Engineer will provide strategic and hands-on support across process development, operations, quality, and regulatory functions, driving process robustness, efficiency, scalability, and compliance across client programs.

WORK LOCATION:

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

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Act as the primary SME for assigned cell therapy unit operations such as cell selection, gene transduction, cell expansion, and cryopreservation within cGMP manufacturing.
• Provide Person-in-Plant (PIP) support during critical operations, ensuring real-time technical guidance and issue resolution.
• Lead complex deviations and investigations to determine root causes and establish corrective and preventative actions (CAPAs).
• Establish and maintain process control strategies for critical process parameters (CPPs) and critical quality attributes (CQAs).
• Conduct data trending, process performance assessments, and modeling to identify improvement opportunities.
• Propose and execute technical projects to optimize yields, reduce cycle times, and enhance process robustness and scalability.
• Lead the development, optimization, and scale-up of manufacturing and laboratory processes across upstream, downstream, or formulation operations.
• Oversee process automation initiatives, including equipment integration and implementation of advanced control strategies.
• Lead commissioning, qualification, and startup of process equipment and automated systems.
• Partner with automation, engineering, and operations teams to implement digital tools, process monitoring systems, and data-driven frameworks.
• Troubleshoot high-impact equipment, process, and automation issues, providing technical direction to junior staff.
• Lead technical transfer of manufacturing processes between development and manufacturing groups or across internal and external sites.
• Ensure process consistency, scalability, and alignment with quality system expectations during transfer.
• Author, review, and approve technical protocols, reports, memos, SOPs, and change control documentation.
• Provide technical data and narrative content for regulatory submissions including IND amendments and CTA filings.
• Support the evaluation, integration, and validation of new technologies or systems to ensure scalability, reliability, and operational readiness.
• Work closely with Quality Assurance, Manufacturing Operations, Development, and Regulatory Affairs to align on technical strategies and execution plans.
• Manage vendor relationships, equipment upgrades,