Project Manager

Fusion Life Sciences technologies LLC; Columbus (OH); On-site; USD 65,000 - 95,000; Full time

Job summary

Fusion Life Sciences technologies LLC in Columbus, OH seeks an experienced Equipment Assembly & Commissioning Engineer to support assembly, installation, commissioning, and qualification of manufacturing equipment in a regulated pharmaceutical environment.

The role requires a Mechanical or Civil Engineering background, knowledge of C&Q processes, GMP standards, and strong documentation skills to support projects across Engineering, Manufacturing, QA, and Validation teams.

Qualifications

• Bachelor’s degree in Mechanical or Civil Engineering.
• Experience in the pharmaceutical or biopharmaceutical industry.
• Knowledge of equipment assembly, installation and qualification.
• Familiarity with C&Q methodologies and equipment qualification documentation.
• Understanding GMP requirements in regulated environments.
• Strong troubleshooting and coordination skills.
• Ability to collaborate with multidisciplinary teams.

Responsibilities

• Support the assembly, installation, and setup of pharmaceutical manufacturing equipment and systems.
• Coordinate equipment installation and commissioning activities per specs and project needs.
• Support C&Q activities, including equipment verification, testing, and qualification documentation.
• Assist with developing, executing, and reviewing commissioning/qualification protocols, test records, and reports.
• Verify equipment functionality, installation readiness, and compliance with design specs.
• Identify assembly issues and coordinate troubleshooting and resolution.
• Collaborate with Engineering, Manufacturing, QA, Validation, and project teams to ensure successful implementation.
• Maintain accurate engineering documents, equipment records, and commissioning/qualification deliverables.
• Ensure work adheres to GMP, safety procedures, and pharmaceutical quality standards.
• Support equipment handover and readiness for manufacturing operations.

Skills

Pharma manufacturing

Equipment assembly

Equipment installation

C&Q

IQ/OQ

GMP

Documentation

Troubleshooting

Mechanical systems

Project coordination

Education

Bachelors in Mechanical/Civil Engineering

Job description

Job Summary

• 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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Key Skills

• Pharmaceutical Manufacturing
• Equipment Assembly
• Equipment Installation
• Commissioning & Qualification (C&Q)
• IQ/OQ
• GMP
• Equipment Qualification
• Functional Testing
• Engineering Documentation
• Troubleshooting
• Mechanical Systems
• Project Coordination