Sterile GMP Commissioning & Qualification Engineer

Technical Source; Lexington (KY); On-site; USD 70,000 - 90,000; Full time

Job summary

Technical Source is looking for Commissioning & Qualification Engineers to support the startup and qualification of new GMP systems in Lexington, KY. The project includes sterile filling lines and lyophilization systems. Candidates should have a Bachelor’s in Engineering, 2-5 years of relevant experience, and familiarity with GMP environments. Responsibilities include developing test plans and coordinating with cross-functional teams. A strong communication skillset is essential in this role.

Qualifications

• 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.

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.

Skills

Commissioning

Qualification

GMP compliance

Technical documentation

Communication skills

Education

Bachelor’s degree in Engineering or related technical discipline

Job description

Technical Source is looking for Commissioning & Qualification Engineers to support the startup and qualification of new GMP systems in Lexington, KY. The project includes sterile filling lines and lyophilization systems. Candidates should have a Bachelor’s in Engineering, 2-5 years of relevant experience, and familiarity with GMP environments. Responsibilities include developing test plans and coordinating with cross-functional teams. A strong communication skillset is essential in this role.