Senior Lab CQV Engineer

Senior Lab CQV Engineer at QvalFocus Inc. Senior Lab CQV Engineer at QvalFocus Inc. in Muskegon, Michigan Posted in about 16 hours ago.

Type:

full-time

Job Description:

Job Overview We are seeking a Senior Lab CQV / Validation Engineer with hands-on experience in commissioning, qualification, and validation of laboratory equipment and systems within regulated pharmaceutical or life sciences environments. The ideal candidate will support

IQ/OQ/PQ

execution, validation documentation, deviation investigations, and cross-functional project activities while ensuring compliance with cGMP and regulatory requirements. Key Responsibilities Execute commissioning, qualification, and validation activities for laboratory equipment and systems. Develop and execute

IQ/OQ/PQ

protocols, validation plans, risk assessments, and summary reports. Support qualification of analytical and computerized laboratory systems. Collaborate with QA, engineering, laboratory teams, and vendors on qualification strategies and testing activities. Investigate deviations, perform risk assessments, and support change control activities. Ensure compliance with FDA cGMP, data integrity, and 21 CFR Part 11 requirements. Qualifications Bachelor's degree in Engineering, Life Sciences, or related field preferred. 4-6 years of CQV, validation, or laboratory systems experience in pharmaceutical or biotech environments. Strong knowledge of equipment qualification lifecycle activities, IQ/OQ/PQ, deviation management, and change control. Experience with laboratory instruments such as

HPLC, GC, TOC

analyzers, balances, and stability chambers preferred. Strong technical writing, communication, and problem-solving skills. Ability to work independently in a fast-paced regulated environment.