Tech Stack

Description

You will lead the engineering and maintenance function supporting cGMP manufacturing, ensuring reliable, compliant, and scalable operations. This high-impact role drives continuous improvement and strategic equipment lifecycle management to support commercial growth.

Requirements

• Bachelor's degree in Engineering with 8+ years pharma/biotech experience or 12+ years regulated manufacturing experience
• 4+ years people management experience leading engineers or technical staff
• Strong knowledge of cGMP/cGTP in aseptic/sterile manufacturing environments
• Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls
• Proven track record improving equipment reliability and reducing downtime

Responsibilities

• Lead, mentor, and develop engineering team (facilities, validation, maintenance, automation)
• Own equipment lifecycle management from design to retirement
• Oversee capital projects from concept through execution
• Establish preventive maintenance and reliability programs to reduce downtime
• Represent Engineering during regulatory audits and ensure cGMP compliance