Senior Process & Mechanical Engineer
Job Title: Senior Process & Mechanical Engineer Pay Rate: $75 - 85/hr Location: Clayton , NC Start Date: ASAP Job Type: Contract (1 year with possible extension) Schedule: M-F 8:00am - 5:00pm Keywords: #PharmaJobs #ProcessEngineer #MechanicalEngineer #GxP #Commissioning #Utilities
JOB RESPONSIBILITIES:
- Lead and execute commissioning and qualification activities (IV/OV/IOQ) for pharmaceutical process and utility systems.
- Design, review, and optimize clean and black utility systems and associated sequences of operations.
- Develop and review sequences of operations for support utility systems, including chilled water, purified water (PW), water for injection (WFI), nitrogen, and compressed air.
- Provide validation support for process vessels, skids, and utility systems in compliance with GxP requirements.
- Support facility design and construction management activities, including construction verification, troubleshooting, and system turnover to operations.
- Lead or coordinate commissioning schedules and cross-functional execution teams during start-up of new or renovated pharmaceutical facilities.
- Collaborate with Manufacturing, Quality, Automation, and Maintenance teams to ensure systems meet operational performance and regulatory standards.
- Support capital projects from conceptual design through construction, commissioning, and validation phases.
REQUIRED QUALIFICATIONS:
- B.S. or M.S. degree in Chemical Engineering or related engineering discipline.
- 8+ years of pharmaceutical GxP experience supporting facility design, construction, commissioning, and validation.
- Strong working knowledge of clean and black utility systems.
- Demonstrated experience with Clean-in-Place (CIP) design and optimization.
- Hands-on experience with Commissioning & Qualification (IV/OV/IOQ) protocols and execution.
- Experience with construction verification and pharmaceutical validation support.
- Proven track record supporting large-scale pharmaceutical capital projects and facility start-ups.
- Ability to lead cross-functional teams and manage contractors in an active manufacturing environment
- Strong technical documentation and communication skills.
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