Senior Manufacturing Engineering Manager

Title:

Senior Manufacturing Engineering Manager Company Description

Vaxess is developing a pipeline of next-generation vaccines and therapeutics on our novel micro‑array patch platform. With only five minutes of wear‑time on the skin, the self‑applied patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Manufacturing Engineering Manager is responsible for building and leading a high‑performing Manufacturing Engineering organization supporting Phase 2 and Phase 3 clinical manufacturing of a highly automated pharmaceutical–medical device combination product manufactured in ISO Class 5 isolator environments and will report to the VP of Manufacturing.

This role provides technical leadership for process development transfer, equipment integration, MES/electronic batch record implementation, validation execution (IQ/OQ/PQ), and establishment of scalable GMP manufacturing systems. The position requires strong problem‑solving capability, hands‑on leadership, and the ability to operate effectively within a fast‑paced startup environment transitioning to late‑stage clinical readiness.

• Build, lead, and develop a team of manufacturing engineers and engineering technicians. Recruit, mentor, and performance‑manage engineering staff and manufacturing technicians.
• Develop training frameworks for GMP technicians and operators supporting highly automated production lines.
• Lead transfer and integration activities of highly automated manufacturing systems, including custom automation and OEM equipment.
• Develop and execute Master Validation Plans (MVPs) covering facilities, utilities, process equipment, and ancillary systems for operation in Grade A/ISO Class 5 isolator‑based manufacturing environments.
• Lead generation, review, and approval of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols.
• Collaborate cross‑functionally to ensure traceability between URS, design specifications, FAT/SAT, and qualification protocols.
• Oversee implementation and lifecycle management of Manufacturing Execution Systems (MES), Electronic Batch Records (E ), Equipment data acquisition systems, Integrated automation platforms.
• Develop SOPs, work instructions, maintenance procedures, and engineering documentation to support validated operations.
• Lead structured root cause investigations (e.g., deviation investigations, CAPAs, equipment failures, yield excursions).
• Apply engineering rigor and statistical methods to improve process capability and equipment performance.
• Scale processes from early clinical manufacturing through Phase 3 readiness, ensuring process robustness and repeatability by the implementation of KPIs for OEE, Throughput, Yield, Deviation rate, Batch release cycle time, Validation execution timelines.
• Partner with Quality, Regulatory, and Supply Chain to ensure phase‑appropriate compliance and scalability.
• Foster a culture of accountability, urgency, technical rigor, and continuous improvement driving operational readiness for increasing clinical demand.

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, or related discipline (Master’s preferred).
• 8–12+ years of experience in pharmaceutical, biotech, or medical device manufacturing.
• Minimum 3–5 years of people management experience leading engineers and/or technicians.
• Direct experience supporting Phase 2 and/or Phase 3 clinical manufacturing environments with combination products, polymer processing and/or unique drug releasing processes/products.
• Demonstrated experience with:
  Master Validation Plan development, IQ/OQ/PQ execution, Process validation, GMP documentation systems and MES and electronic batch record implementation.
• Experience with highly automated manufacturing lines and equipment integration.
• Experience operating within Grade A/ISO Class…