Lab Instrument Validation Engineer

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

• 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
• nt Hands-on experience operating lab instruments and diagnostic equipment, including Keyence and SATMZ brand syste
• ms Experience training or mentoring technical staff on equipment u
• se Strong knowledge of cGMP, data integrity, and validation lifecycle principl

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