CQV Engineer / Validation Engineer (W2)

Position OverviewWe are seeking a CQV Engineer to support change control and deviation management activities within a regulated cGMP environment. This role is critical to maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed.The ideal candidate will have hands-on experience in change management, deviation investigations, and validation/CQV lifecycle support within pharmaceutical or medical device manufacturing.Key ResponsibilitiesChange Control ManagementAuthor, review, and manage change controls impacting systems, equipment, and processesPerform impact assessments related to product quality, validated state, and regulatory requirementsCollaborate with cross-functional teams to ensure timely and compliant implementationSupport updates to validation documentation (IQ/OQ/PQ, protocols, reports)Deviation ManagementLead and support deviation investigations, including root cause analysis and CAPA developmentEnsure deviations are properly documented, investigated, and closed on timePartner with Quality to ensure compliance with internal procedures and regulatory expectationsCQV & Compliance SupportEnsure adherence to cGMP and Good Documentation Practices (GDP)Support validation impact assessments and execution activitiesReview and approve validation and technical documentationParticipate in audits and inspections as a subject matter expertCollaboration & Continuous ImprovementWork closely with Manufacturing, QA, Engineering, and Automation teamsSupport continuous improvement initiatives related to quality systems and CQV processesCommunicate project updates, risks, and issues to stakeholdersQualificationsBachelor’s degree in Engineering, Life Sciences, or related field3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industryStrong experience with change control systems and deviation investigationsSolid understanding of cGMP and GDP environmentsExperience with validation lifecycle activities (IQ/OQ/PQ) preferredFamiliarity with device assembly/packaging operations is a plusStrong technical writing and communication skills