Senior Validation Engineer: CSV & GMP Leader

Beacon Hill; Indianapolis (IN); On-site; USD 110,000 - 160,000; Full time

Job summary

Beacon Hill is seeking an experienced Senior Validation Engineer to lead validation, qualification, and calibration activities across capital projects, manufacturing operations, and laboratory systems. You will ensure equipment, utilities, and computerized systems meet regulatory and quality requirements in GMP environments.

You will collaborate with Engineering, Quality, Manufacturing, Operations, and Regulatory teams to drive compliance, author IQ/OQ/PQ protocols, and support audits and

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 5+ years in validation, qualification, calibration, or commissioning within GMP environments.
• Strong understanding of cGMP, FDA requirements, ASTM E2500, ICH, GAMP 5, 21 CFR Part 11, Data Integrity.

Responsibilities

• Lead validation activities from planning to final approval.
• Develop and maintain VMPs, validation strategies, qualification plans, and lifecycle documents.
• Author/review/execute IQ/OQ/PQ protocols, test scripts, validation reports, and traceability matrices.
• Support capital expansions, facility upgrades, equipment installations, and process improvements.

Skills

Validation engineering

CSV

IQ/OQ/PQ

Technical writing

Education

Bachelor’s degree in Engineering

Tools

Kneat

ValGenesis

MasterControl

Veeva

TrackWise

Job description

Beacon Hill is seeking an experienced Senior Validation Engineer to lead validation, qualification, and calibration activities across capital projects, manufacturing operations, and laboratory systems. You will ensure equipment, utilities, and computerized systems meet regulatory and quality requirements in GMP environments.

You will collaborate with Engineering, Quality, Manufacturing, Operations, and Regulatory teams to drive compliance, author IQ/OQ/PQ protocols, and support audits and