Project Manager

Fusion Life Sciences technologies LLC

Columbus, OH

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

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