Process Engineer
About The Position
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. 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.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related technical field
- 5+ years of experience in pharmaceutical/biotech or medical device manufacturing environments
- Demonstrated 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
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
Benefits
- Market competitive base salary
- Annual incentive plan
- Robust benefit offerings
- Ongoing recognition and career development opportunities
- Generous flexible paid time off program
- Company-paid holidays
- Flexible working hours
- Fully remote work options for most positions
- Ability to work “almost anywhere”
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What This Job Offers
Job Type
Full-time
Career Level
Senior
