Process Engineer II

Roles and Responsibilities

• Represent Site MSAT on project teams as technical SME; interface with Global MSAT, Operations, and Quality.
• Develop process understanding and expertise.
• Author, review, and own process documentation (technical documents, test protocols, batch records, process descriptions, SOPs).
• Author, review, and lead change controls; manage change implementation as assigned change agent.
• Partner with Manufacturing to develop high-quality batch records, robust processes, and technology solutions.
• Participate and/or lead investigations for process/new product implementation; drive CAPA implementation from approval through closure and effectiveness check.
• Participate in quality and technical risk assessments.
• Support technology transfer and new production introduction.
• Monitor and report process performance data analysis.
• Partner with Validation and Quality on equipment onboarding and periodic review programs as process owners.
• Provide 24/7 on-call support during production.
• Apply Operational Excellence principles to lead continuous improvement.

• BS in Engineering with 2–4 years pharma/biotech experience, or MS in Engineering with 1+ year experience.
• Experience supporting process/technology transfer (commercial campaign support is a plus).
• Solid upstream processing knowledge; hands‑on single‑use bioreactor operations and perfusion technology (manufacturing scale or process development).
• Solid GMP and quality systems knowledge for manufacturing/new product introduction.
• Working knowledge of manufacturing process equipment and automation systems.
• Ability to organize, analyze/interpret, and communicate process data.
• Strong quality focus and attention to detail; effective time/task management.
• Interpersonal and collaborative skills.
• Excellent English verbal/written communication; interface with all organizational levels.

• Ability to navigate regulatory CMC documents.
• DeltaV experience.
• Late‑stage manufacturing, technical transfer, and process validation study experience.
• Audit/inspection support experience as presenter or support staff.

Benefits:
Base pay range $86,250–$90,000; discretionary annual bonus;
Medical/Dental/Vision; short‑ and long‑term disability; basic life insurance; 401(k) match; flexible work; paid time off and paid holidays; wellness and transportation benefits.