Senior Process Engineer: Terminal Sterilization (Remote)

Doist; Plainville (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Market-competitive base salary

Robust benefits

Career development opportunities

Generous paid time off

Company-paid holidays

Flexible working hours

Remote work options for most positions

Job summary

Syner-G is seeking a Sr. Process Engineer to lead the terminal sterilization program, develop process diagrams, define cycle parameters, and align standards with GMP and FDA expectations.

You will collaborate with CQV, engineering, and operations to implement robust sterilization solutions. The role involves start-up support, validation, and staff training, with travel up to 100% as project demands require.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 5+ years in pharma/biotech or medical device manufacturing environments.
• Hands-on expertise with terminal sterilization technologies (steam, EO, dry heat).

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

Stakeholder influence

Cross-functional leadership

Technical writing

Team leadership

Problem solving

Education

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Job description

Syner-G is seeking a Sr. Process Engineer to lead the terminal sterilization program, develop process diagrams, define cycle parameters, and align standards with GMP and FDA expectations.

You will collaborate with CQV, engineering, and operations to implement robust sterilization solutions. The role involves start-up support, validation, and staff training, with travel up to 100% as project demands require.