Job Title: Senior Engineer
Location: New Albany, Ohio (On-Site)
Job Summary: We are representing a company seeking a Senior Engineer to support validated laboratory operations, compliance readiness, and hands-on technical execution within a fast-paced GMP environment. Our team is looking for someone who can own laboratory equipment, support investigations, and help maintain inspection-ready systems while partnering across Manufacturing, Engineering, Quality, and Process Development.
Responsibilities:
- Lead validation and CQV activities for laboratory systems and equipment, including qualification, periodic review, lifecycle management, and maintaining a validated state.
- Own day-to-day PD laboratory readiness, including equipment operation, troubleshooting, maintenance coordination, documentation, and compliant use of laboratory spaces.
- Support manufacturing issues and forensic investigations by performing preliminary diagnostic assessments, assisting with deviations, CAPAs, change controls, and risk assessments.
- Collaborate cross-functionally on lab build-outs, method transfers, challenge kit management, training, and ongoing inspection readiness.
Required:
- Master’s degree and/or 2 years in a GMP-regulated environment, or Bachelor’s degree and/or 5 years in a GMP-regulated environment.
- Hands-on experience with the end-to-end CQV/validation lifecycle for GMP laboratory instruments or equipment, including URS, risk assessment, commissioning, IQ/OQ/PQ or CQ, protocol execution, deviations, change control, validation reports, and periodic review.
- Direct experience working in a GMP laboratory or manufacturing-support laboratory with equipment operation, troubleshooting, maintenance/readiness, documentation, data integrity, and inspection readiness.
- Experience developing, qualifying, maintaining, or using challenge kits, reference standards, known defect samples, or other verification materials.
- Ability to support advanced inspection or diagnostic tools such as microscopy, vision systems, X-ray inspection, dimensional inspection, or similar technologies.
- Willingness to support off-shift, extended, or adjusted hours when manufacturing or investigation support requires it.
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