Project Engineer, Quality Engineering

This role will lead engineering projects within an aseptic pharmaceutical environment, supporting the lifecycle of critical manufacturing equipment and facilities, including washers, autoclaves, and cleanroom systems. The position requires strong technical expertise, project leadership skills, and hands‑on experience with regulated GMP environments.

• Lead and manage engineering projects from concept through execution and handover within an aseptic pharmaceutical manufacturing environment
• Serve as the technical lead for equipment‑related projects, with a strong focus on washers, autoclaves, and associated small parts and components
• Coordinate design, installation, commissioning, qualification, and validation (DQ/IQ/OQ/PQ) activities in compliance with GMP requirements
• Collaborate cross‑functionally with Manufacturing, Quality, Validation, EHS, and external vendors
• Ensure cleanroom and aseptic process requirements are met during project execution
• Manage project scope, timelines, budgets, and risks while ensuring compliance with internal standards and regulatory expectations
• Support troubleshooting, upgrades, and continuous improvement initiatives for existing equipment and facilities
• Prepare and review technical documentation, risk assessments, and change controls
• Maintain engineering standards, safety policies, and regulatory guidelines

• Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Electrical, or related discipline)
• 5+ years of experience in pharmaceutical or biopharmaceutical manufacturing
• Strong background in aseptic processing and GMP‑regulated environments
• Proven experience working with washers, autoclaves, and cleanroom equipment
• Experience handling small equipment parts and precision components within manufacturing systems
• Solid understanding of equipment qualification and validation