Project Engineer

Role Overview

We are seeking an experienced Project Engineer to support process equipment projects within a GMP-regulated pharmaceutical manufacturing environment.

This role will focus on qualification of new process equipment, brownfield modifications, technology transfer activities, and supporting commissioning through to validated state. The successful candidate will work from a client-side perspective and collaborate closely with QA, EHS, Automation, Engineering, and Operations teams to ensure compliant and efficient project execution.

Key Responsibilities

Process Equipment Project Delivery

• Lead and support qualification of new process equipment from URS through FAT, SAT, commissioning, IQ/OQ/PQ and handover.

• Review and contribute to URS, risk assessments, and validation documentation.

• Coordinate vendors during FAT and site activities.

• Support troubleshooting and resolution of technical issues during start-up and qualification.

Brownfield & Modification Projects

• Support modification and upgrade projects within a live manufacturing environment.

• Assess technical and GMP impact of equipment changes.

• Coordinate shutdown planning and minimize disruption to operations.

Technology Transfer Support

• Support technical transfer of process equipment and systems from design to execution.

• Ensure equipment configuration aligns with process and validation requirements.

• Work with global stakeholders (if applicable) during transfer activities.

GMP & Change Control

• Raise and manage change controls related to equipment and process modifications.

• Perform impact and risk assessments on validated systems.

• Ensure alignment with site quality systems and regulatory expectations.

• Support deviation investigations related to equipment qualification or commissioning.

Stakeholder Management

• Act as equipment/package owner from a client perspective.

• Coordinate closely with QA, EHS, Automation, Engineering, and Operations teams.

• Lead cross-functional meetings and track action item closure.

• Escalate project risks and drive resolution.

Required Skills & Experience

• Degree in Chemical Engineering, Mechanical Engineering, or related discipline.

• 5-10+ years of experience in pharmaceutical or biologics manufacturing.

• Strong experience in process equipment commissioning and qualification (IQ/OQ/PQ).

• Experience working in GMP-regulated environments.

• Hands-on exposure to FAT/SAT and start-up support.

• Experience managing change controls and supporting validation documentation.

• Strong stakeholder coordination and communication skills.