CQV Engineer

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.