Process Engineer

About the role

We are seeking an experienced Sr. Process Engineer to support the development and implementation of a comprehensive terminal sterilization program. This individual will play a critical role in establishing the technical and operational framework for sterilization processes that ensure product safety, regulatory compliance, and manufacturing readiness.

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
• Possess strong program development experience and collaborate cross-functionally with CQV, engineering, and operations teams to design, implement, and execute robust sterilization solutions
• 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

Qualifications & Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related technical field
• 5+ years of experience in pharmaceutical/biotech or medical device manufacturing environments
• Demonstrated hands-on expertise with terminal sterilization technologies (e.g., steam, EO, dry heat, or other validated methods)
• Experience designing and implementing sterilization programs or systems at a site or program level
• Experience supporting new facility start-ups or program build-outs
• Working knowledge of CQV, validation, and GMP compliance standards
• Strong documentation, technical writing, and cross-functional collaboration skills
• Background in process engineering or validation leadership
• Familiarity with regulatory inspections and audit readiness
• Ability to influence stakeholders and lead multi-disciplinary teams