CQV Engineer (Albany)

Job Title: CQV Engineer (Lab Equipment & Systems) Location: Albany, NY Job Type: Long Term W2 Contract Job Summary: We are seeking a CQV Engineer with experience in commissioning, qualification, and validation (CQV) of laboratory equipment in a GMP-regulated pharmaceutical or biotechnology environment. This role supports equipment lifecycle activities including onboarding, documentation, change control (ECN), and data integrity compliance. The ideal candidate will have hands-on experience with lab systems, strong technical writing skills, and the ability to work cross-functionally with Process Sciences and Quality teams.

Key Responsibilities: Perform commissioning and qualification (IQ/OQ support) for laboratory equipment and systems. Execute equipment onboarding ensuring compliance with GMP, data integrity, and regulatory requirements. Provide system administration and technical support, including basic troubleshooting of lab instruments.

Work with lab equipment such as SoloVPE, Nova Flex2, Kingfisher Apex, LabChip, Wave Rocker, and Sartocheck. Support and manage Engineering Change Notices (ECNs) and change control activities. Author and maintain technical documentation including SOPs, protocols, reports, and configuration specifications.

Collaborate with Process Sciences, Quality, and Manufacturing teams to ensure equipment readiness for GMP operations. Perform verification and validation activities to ensure systems meet intended use. Support data integrity initiatives and ensure accurate documentation practices.

Manage legacy equipment (up to 8 years old), including documentation remediation and data organization. Work in controlled/GMP environments, including gowning as required. Travel between buildings to support equipment and system needs.

Required Qualifications: Bachelor’s degree in Engineering, Life Sciences, or related field. 3+ years of experience in CQV / Validation / Commissioning within pharma or biotech industry. Strong knowledge of GMP, FDA regulations, and data integrity (ALCOA principles). Hands-on experience with laboratory equipment and systems qualification.

Experience with change control systems (ECN / CAPA). Strong skills in technical writing and documentation (SOPs, protocols, reports). Ability to work independently and in cross-functional teams.

Willingness to work in cleanroom / controlled environments. Preferred Qualifications: Experience with Biovia U Lab or similar LIMS / lab informatics systems. Familiarity with risk-based validation approaches.

Experience supporting equipment lifecycle management. Prior experience with legacy system remediation.