Senior Process Engineer - Sterilization Systems (Remote)

Syner-G; Plainville (MA); Remote; USD 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Fully remote work options

Office locations: Greater Boston, San-

Office locations: Greater Boston, San-

Zusammenfassung

Syner-G in Plainville, MA is seeking an experienced Sr. Process Engineer to lead the terminal sterilization program development and implementation.

You will define recipes, cycles, and validation strategies that ensure GMP compliance and manufacturing readiness across sites. Travel up to 100% may be required as projects demand, and you will collaborate with CQV, engineering, and operations teams to deliver robust, scalable sterilization solutions that support patient safety and life-enhancing

Qualifikationen

• Bachelor’s degree in Engineering, Life Sciences, or related technical field with 5+ years in pharmaceutical/biotech or medical device manufacturing environments.
• Hands-on experience with terminal sterilization technologies (steam, EO, dry heat, or validated methods).
• Experience designing and implementing sterilization programs or systems at site/program level; supporting new facility start-ups or program build-outs.

Aufgaben

• 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.

Kenntnisse

CQV knowledge

Validation leadership

GMP compliance

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Engineering/Life Sciences

Jobbeschreibung

Syner-G in Plainville, MA is seeking an experienced Sr. Process Engineer to lead the terminal sterilization program development and implementation.

You will define recipes, cycles, and validation strategies that ensure GMP compliance and manufacturing readiness across sites. Travel up to 100% may be required as projects demand, and you will collaborate with CQV, engineering, and operations teams to deliver robust, scalable sterilization solutions that support patient safety and life-enhancing