Job Description

Technical Source is currently supporting a major sterile manufacturing expansion in a Lexington, KY facility. This project is being led by our partner and involves the installation and startup of new aseptic manufacturing and lyophilization systems as part of a large-scale sterile fill-finish expansion.

We are seeking Commissioning & Qualification Engineers to support the startup, testing, and qualification of new GMP manufacturing systems and utilities as the project progresses toward operational readiness.

This role will work closely with partner engineering teams, client-owner operations, and quality groups to ensure systems are commissioned and qualified in accordance with regulatory requirements and project schedules.

Project Scope:

The Lexington expansion includes installation and qualification of new sterile drug product manufacturing equipment, including:

• Sterile filling lines
• Lyophilizers (freeze dryers)
• Vial washing and sterilization systems
• Isolators and aseptic processing equipment
• Clean utilities (WFI, clean steam, process gases)
• HVAC and environmental control systems
• Packaging and supporting production equipment
  

Responsibilities:

• Support commissioning and qualification activities for new sterile manufacturing equipment and utilities
• Develop and execute commissioning test plans and IQ/OQ protocols
• Coordinate testing with engineering, automation, quality, and operations teams
• Assist with equipment installation verification and turnover from construction to operations
• Troubleshoot issues identified during commissioning or qualification
• Review vendor documentation, design packages, and P&IDs
• Support documentation packages required for GMP compliance and regulatory readiness
• Participate in punch-list resolution and system startup activities

Qualifications:

• Bachelor’s degree in Engineering or related technical discipline
• 2 - 5 years of experience in commissioning, qualification, or validation
• Experience working in GMP regulated manufacturing environments
• Experience with sterile manufacturing or aseptic processing preferred
• Familiarity with qualification of:
• sterile fill-finish systems
• lyophilizers
• clean utilities (WFI, clean steam, HVAC)
• Ability to read engineering drawings, P&IDs, and system design documentation
• Strong communication skills and ability to work within multi-disciplinary project teams