Senior Validation Engineer

Job Description
We are seeking a skilled Senior Lab CQV / Senior Validation Engineer with hands-on experience qualifying and validating a wide range of laboratory equipment and systems within a regulated pharmaceutical or life sciences environment. The ideal candidate will have direct experience executing commissioning and qualification activities independently, collaborating with laboratory stakeholders and instrument vendors, and supporting lifecycle validation activities for both simple and complex laboratory instrumentation.

Job Responsibilities:
Execute commissioning, qualification, and validation activities for laboratory instruments and systems, including IQ/OQ/PQ execution and protocol development
Support qualification of both standalone and integrated laboratory equipment, including analytical and computerized laboratory systems
Interface directly with laboratory personnel, engineering teams, QA, and instrument vendors to define testing scope, acceptance criteria, and qualification strategy
Draft, review, and execute validation lifecycle documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Summary Reports, deviations, and change controls
Perform impact assessments and risk assessments to determine system criticality, GxP impact, and qualification requirements
Troubleshoot qualification issues, investigate deviations, and support root cause analysis activities during execution
Maintain accurate, detailed, and compliant qualification documentation in accordance with cGMP and internal quality standards
Support system integrations and assess data flow between laboratory instruments, software platforms, and enterprise systems
Coordinate qualification activities with project schedules and cross-functional stakeholders to ensure timely project execution
Ensure compliance with applicable regulatory requirements including FDA cGMP guidelines, data integrity expectations, and 21 CFR Part 11 requirements

Job Requirements:
Bachelor’s Degree in Engineering, Life Sciences, Computer Science, or related technical discipline preferred
4–6 years of experience in CQV, qualification, validation, or laboratory systems support within the pharmaceutical, biotech, or life sciences industry
Direct hands-on experience qualifying complex laboratory instruments and systems in a regulated cGMP environment
Strong knowledge of equipment qualification lifecycle activities including commissioning, IQ/OQ/PQ execution, deviation management, and change control
Experience working with laboratory instrumentation such as HPLC, GC, TOC analyzers, balances, spectrophotometers, stability chambers, or similar analytical equipment preferred
Understanding of computerized laboratory systems and system integrations is preferred, but primary focus is on equipment qualification and CQV execution
Familiarity with risk-based validation approaches and data integrity requirements
Knowledge of 21 CFR Part 11 and GxP compliance expectations
Strong technical writing, communication, organizational, and problem-solving skills
Ability to work independently with minimal oversight while collaborating effectively across functional teams
Show more Show less