Project Manager, Validation Engineer, Pharma Engineer
Job in
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-10-21
Listing for:
Fusion Life Sciences technologies LLC
Full Time
position Listed on 2026-10-21
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
- We are seeking an experienced Equipment Assembly & Commissioning Engineer with a pharmaceutical industry background to support the assembly, installation, commissioning, and qualification of manufacturing equipment in a regulated pharmaceutical environment. The ideal candidate will have a Mechanical or Civil Engineering background and knowledge of Commissioning and Qualification (C&Q) processes, GMP requirements, and equipment documentation.
- Support the assembly, installation, and setup of pharmaceutical manufacturing equipment and associated systems.
- Coordinate equipment installation and commissioning activities in accordance with approved engineering specifications and project requirements.
- Support Commissioning and Qualification (C&Q) activities, including equipment verification, functional testing, and qualification documentation.
- Assist with developing, executing, and reviewing commissioning and qualification protocols, test records, and reports.
- Verify equipment functionality, installation readiness, and compliance with design specifications and operational requirements.
- Identify equipment assembly issues, installation discrepancies, and technical problems; coordinate troubleshooting and resolution.
- Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and project teams to ensure successful equipment implementation.
- Maintain accurate engineering documentation, equipment records, and commissioning/qualification deliverables.
- Ensure work is performed in accordance with applicable GMP requirements, safety procedures, and pharmaceutical quality standards.
- Support equipment handover and readiness for manufacturing operations.
- Bachelor’s degree in Mechanical Engineering or Civil Engineering.
- Experience working in the pharmaceutical or biopharmaceutical industry.
- Knowledge of equipment assembly, installation, commissioning, and qualification activities.
- Familiarity with C&Q methodologies and equipment qualification documentation.
- Understanding of GMP requirements and regulated manufacturing environments.
- Strong troubleshooting, documentation, coordination, and problem-solving skills.
- Ability to collaborate with multidisciplinary engineering and quality teams.
- Hands-on experience with pharmaceutical manufacturing equipment installation and assembly.
- Experience with commissioning and qualification protocols, functional testing, and equipment acceptance activities.
- Familiarity with IQ/OQ and equipment qualification documentation.
- Exposure to pharmaceutical facility projects, equipment startup, and operational readiness.
- Knowledge of engineering drawings, equipment specifications, and installation requirements.
- Pharmaceutical Manufacturing
- Equipment Assembly
- Equipment Installation
- Commissioning & Qualification (C&Q)
- IQ/OQ
- GMP
- Equipment Qualification
- Functional Testing
- Engineering Documentation
- Troubleshooting
- Mechanical Systems
- Project Coordination
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