Process Engineer

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Synergbiopharma.com POSITION OVERVIEW: 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. The ideal candidate brings deep technical expertise in terminal sterilization methods, strong program development experience, and the ability to collaborate cross-functionally with CQV, engineering, and operations teams to design, implement, and execute robust sterilization solutions. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations.

KEY 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

: Education: Bachelor’s degree in Engineering, Life Sciences, or related technical field 5+ years of experience in pharmaceutical/biotech or medical device manufacturing environments Technical Experience: 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 Knowledge, Skills, and Abilities : Working knowledge of CQV, validation, and GMP comp

QUALIFICATIONS

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