Senior Process Engineer — Terminal Sterilization & GMP

Synerg; Plainville (MA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Remote work options

Office locations: Greater Boston, San-

Job summary

Syner-G is seeking a Sr. Process Engineer to lead the development and implementation of a comprehensive terminal sterilization program.

You will shape the technical and operational framework to ensure product safety, regulatory compliance, and manufacturing readiness, collaborating with CQV, engineering, and operations teams. The role requires hands-on sterilization experience across steam, EO, dry heat, or validated methods, and a track record in program development and site-level

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field; 5+ years' experience in pharmaceutical/biotech or medical device manufacturing.

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.

Skills

Sterilization expertise

Cross-functional collaboration

Validation leadership

Documentation & technical writing

Regulatory compliance knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Syner-G is seeking a Sr. Process Engineer to lead the development and implementation of a comprehensive terminal sterilization program.

You will shape the technical and operational framework to ensure product safety, regulatory compliance, and manufacturing readiness, collaborating with CQV, engineering, and operations teams. The role requires hands-on sterilization experience across steam, EO, dry heat, or validated methods, and a track record in program development and site-level