Sr. Process Engineer
Listed on 2026-02-28
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Engineering
Process Engineer, Manufacturing Engineer, Quality Engineering, Validation Engineer
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 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.
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Position OverviewWe are seeking an experienced Sr. Process Engineer to support the development and implementation of a comprehensive terminal sterilization program. This individual will play a critical role in establishing the technical and operational framework for sterilization processes that ensure product safety, regulatory compliance, and manufacturing readiness. The ideal candidate brings deep technical expertise in terminal sterilization methods, strong program development experience, and the ability to collaborate cross‑functionally with CQV, engineering, and operations teams to design, implement, and execute robust sterilization solutions.
WorkLocation
Travel to client sites may be required up to 100%, based on project demands and client expectations.
Key Responsibilities- Develop and document detailed sterilization process flow diagrams and program architecture
- Define sterilization recipes, cycle parameters, and operating ranges
- Establish overall sterilization program strategy, standards, and best practices
- Partner with CQV, engineering, and manufacturing teams to support execution and implementation
- Lead troubleshooting and technical problem‑solving during cycle development and start‑up
- Support commissioning, qualification, and validation activities (protocol development, execution support, deviation resolution)
- Ensure compliance with GMP, FDA, and regulatory requirements
- Provide subject matter expertise and training to operations staff
- Drive readiness for manufacturing operations and sustainable long‑term performance
Bachelor’s degree in Engineering, Life Sciences, or related technical field.
Qualifications & Requirements- 5+ years of experience in pharmaceutical/biotech or medical device manufacturing environments
- Hands‑on expertise with terminal sterilization technologies (e.g., steam, EO, dry heat, or other validated methods)
- Experience designing and implementing sterilization programs or systems at a site or program level
- Experience supporting new facility start‑ups or program build‑outs
- Working knowledge of CQV, validation, and GMP compliance standards
- Strong documentation, technical writing, and cross‑functional collaboration skills
- Background in process engineering or validation leadership
- Familiarity with regulatory inspections and audit readiness
- Ability to influence stakeholders and lead multi‑disciplinary teams
Physical…
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