Remote Senior Process Engineer: Sterilization Programs

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

Benefits offered by this job

Remote work options

Job summary

Syner-G is seeking a Sr. Process Engineer to lead the development and implementation of a comprehensive terminal sterilization program. The role focuses on creating the technical and operational framework for sterilization processes that ensure product safety, regulatory compliance, and manufacturing readiness.

You will work with CQV, engineering, and operations to design and execute robust solutions. The ideal candidate will bring deep technical expertise in terminal sterilization methods,

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field with 5+ years in pharma/biotech or medical device manufacturing.

Responsibilities

• Develop sterilization process flow diagrams and program architecture.
• Define sterilization recipes, cycle parameters, and operating ranges.
• Establish overall sterilization program strategy, standards, and best practices.
• Collaborate with CQV, engineering, and manufacturing for execution.
• Lead troubleshooting during cycle development and start-up.
• Support commissioning, qualification, and validation activities.

Skills

Terminal sterilization

Validation leadership

Process engineering

CQV collaboration

GMP compliance

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. The role focuses on creating the technical and operational framework for sterilization processes that ensure product safety, regulatory compliance, and manufacturing readiness.

You will work with CQV, engineering, and operations to design and execute robust solutions. The ideal candidate will bring deep technical expertise in terminal sterilization methods,