Lab Instrument Validation Engineer

United Pharma; Kentucky; On-site; USD 85,000 - 110,000; Full time

Job summary

United Pharma is seeking a hands-on Lab Instrument Validation Engineer to support Process Development (PD) laboratory operations in an operational readiness capacity.

The role serves as the primary trainer and technical resource for Engineering staff on the proper use, troubleshooting, and routine operation of PD lab instruments and diagnostic equipment, while also validating lab instruments and equipment as needed.

Qualifications

• BS/MS in Engineering, Life Sciences, or related field.
• 2–5+ years in a GMP-regulated environment.
• Hands-on CQV (Commissioning, Qualification, and Validation) experience with lab instruments and equipment.
• Hands-on experience operating lab instruments and diagnostic equipment, including Keyence and SATMZ brand systems.
• Experience training or mentoring technical staff on equipment use.
• Strong knowledge of cGMP, data integrity, and validation lifecycle principles.

Responsibilities

• Serve as the primary trainer and technical resource for Engineering staff on proper use, troubleshooting, and routine operation of PD lab instruments and diagnostic equipment.
• Validate PD lab instruments and equipment as needed and partner with Manufacturing, Engineering, and Quality teams.
• Develop and deliver hands-on training, create training materials and job aids, and run equipment walkthroughs and demonstrations.

Skills

CQV experience

Staff training

Lab instrument operation

Data integrity

GMP familiarity

Education

BS/MS in Engineering, Life Sciences, or related field

Tools

Keyence

SATMZ equipment

Job description

We are seeking a hands-on Lab Instrument Validation Engineer to support Process Development (PD) laboratory operations in an operational readiness capacity. This individual will serve as the primary trainer and technical resource for Engineering staff on the proper use, troubleshooting, and routine operation of PD lab instruments and diagnostic equipment, while also validating lab instruments and equipment as needed — partnering closely with Manufacturing, Engineering, Quality, and other cross-functional teams.

Key focus areas include validating PD lab instruments and systems, developing and delivering hands-on training on validated equipment, creating training materials and job aids, running equipment walkthroughs and demonstrations, and confirming engineer competency/readiness for ongoing operational use. The engineer will also maintain day-to-day ownership of PD lab spaces and equipment, support periodic reviews and lifecycle management, and help resolve CAPAs, change controls, and deviations in alignment with cGMP and data integrity requirements

Must-have

• s:BS/MS in Engineering, Life Sciences, or related fie
• ld2–5+ years in a GMP-regulated environment (depending on degre
• e)Hands-on CQV (Commissioning, Qualification, and Validation) experience with lab instruments and equipme
• ntHands-on experience operating lab instruments and diagnostic equipment, including Keyence and SATMZ brand syste
• msExperience training or mentoring technical staff on equipment u
• seStrong knowledge of cGMP, data integrity, and validation lifecycle principl

Nice-to-hav

• es:Familiarity with barcode scanners and device assembly machi
• nesChallenge kit testing experie
• ncePrior experience developing training/SOP documentation or leading equipment onboarding for new us