Senior Process Engineer: Sterilization Programs (Remote)

Syner G; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Fully remote work options

Flexible paid time off

Flexible working hours

Job summary

Syner-G in the United States is seeking an experienced Sr. Process Engineer to support terminal sterilization program development and implementation, ensuring product safety, regulatory readiness, and manufacturing readiness.

The role requires deep technical expertise in terminal sterilization, collaboration with CQV, engineering, and operations, and the ability to lead cross-functional teams through cycle development and validation in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field with 5+ years pharma/biotech experience.
• Hands-on expertise with terminal sterilization technologies (steam, EO, dry heat, etc.).
• Experience designing sterilization programs at site or program level; start-ups a plus.

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

Terminal sterilization

Program design

CQV collaboration

Validation leadership

GMP compliance

Education

Bachelor's degree in Engineering

Job description

Syner-G in the United States is seeking an experienced Sr. Process Engineer to support terminal sterilization program development and implementation, ensuring product safety, regulatory readiness, and manufacturing readiness.

The role requires deep technical expertise in terminal sterilization, collaboration with CQV, engineering, and operations, and the ability to lead cross-functional teams through cycle development and validation in a fast-paced biopharma environment.