Sr. Process & Mechanical Engineer

Overview

Senior Process & Mechanical Engineer (Pharmaceutical Utilities) - Contract, Site-Based

We are seeking a Senior Process & Mechanical Engineer to provide on-site contract support within a pharmaceutical GxP manufacturing environment. This role is focused on utility and process systems and supports capital projects and operational readiness activities from detailed design through construction, commissioning, qualification, and handover to site operations.

The position requires strong hands-on experience working directly at a manufacturing site, supporting field execution, start-up activities, and system performance in collaboration with site stakeholders.

• Execute on-site commissioning and qualification activities (IV/OV/IOQ) for pharmaceutical process and utility systems.

• Review, optimize, and support utility system designs, field installations, and control sequences.

• Develop and review sequences of operations for site utility systems, including chilled water, purified water, water for injection (WFI), nitrogen, and compressed air.

• Provide validation and documentation support for process vessels, skids, and utility systems in accordance with GxP requirements.

• Support construction verification, field troubleshooting, and punch-list resolution to ensure systems are ready for start-up and qualification.

• Coordinate and support commissioning execution activities during start-up of new or modified systems.

• Work closely with site Manufacturing, Quality, Automation, Engineering, and Maintenance teams to ensure systems meet operational, safety, and regulatory expectations.

• Support system turnover and handover to site operations and maintenance teams.

• Clean-in-Place (CIP) design and optimization

• Commissioning and qualification (IV/OV/IOQ)

• Clean and black utility systems and associated process equipment

• Construction verification and field execution

• Pharmaceutical validation support

• Sequence of operations development for utility systems

• B.S. or M.S. in Chemical Engineering or a related discipline

• 8+ years of pharmaceutical GxP experience supporting site-based engineering, construction, commissioning, and validation activities

• Strong working knowledge of clean and black utility systems

• Demonstrated experience supporting on-site pharmaceutical capital projects and facility start-ups

• Ability to work independently in a site-based, fast-paced manufacturing environment

• Strong communication skills and ability to collaborate with site teams and external contractors