Lead Process/Project Engineer (Pharma/Biotech)

About the role

The Lead Process/Project Engineer will own the full lifecycle of equipment packages for pharma and biotech projects, from concept through design, testing, installation and qualification. You will lead a team of process engineers and ensure delivery against schedule, budget and quality standards in a cGMP environment.

Key responsibilities

• Manage equipment package ownership covering engineering design, build, FAT, installation and commissioning.
• Oversee a team of 5‑10 Process Engineers to deliver detailed design, URS development, FAT, SAT, DQ, IQ, OQ and PQ.
• Ensure compliance with internal quality standards and cGMP requirements throughout the project.
• Coordinate with manufacturing, validation, quality and project engineering functions for change implementation.
• Drive on‑time delivery of packages while managing schedule, budget and risk.
• Support installation, commissioning and qualification activities on‑site.
• Perform any additional tasks assigned by the supervisor/manager.

Required profile

• Advanced degree in Chemical Engineering, Chemistry or related field.
• 10‑15 years of process engineering experience in the biologics/pharma industry.
• Proven ability to lead and develop a team of process engineers.
• Strong understanding of cGMP and validation requirements.
• Experience with autoclave, glove box and CIP skid projects is preferred.

Required skills

• Equipment design and package ownership.
• Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
• Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Upstream, downstream and central services process operations.
• cGMP compliance and validation.
• Installation, commissioning and qualification of process equipment.