Validation Engineer (CQV) (Devens)

Job Title: CQV Engineer (Process Equipment – Execution Focus)Location: Devens, MA (Onsite)Duration: 3–4 MonthsSchedule: First Shift (7:00 AM – 2:00 PM, Monday–Friday;)Position OverviewWe are seeking two experienced CQV Engineers to support a large-scale cell culture facility expansion within an existing GMP environment. This role focuses strictly on execution of pre-written validation protocols in ValGenesis and hands-on qualification of process equipment.The resources will support equipment installation, system verification, IQ/OQ execution, and post-qualification activities for newly installed equipment arriving in mid-June. This is a fast-paced, timeline-driven project requiring strong independent execution skills and experience in biologics manufacturing environments.Key ResponsibilitiesCQV Execution (Primary Focus)Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.Perform detailed walkdowns of systems, verifying field installation against approved drawings and specifications.Confirm equipment configuration, utilities, and process flow alignment with functional design.Verify maintenance systems are active and properly integrated.Execute wet testing and operational checks.Support SIP/CIP cycle verification and development in coordination with Manufacturing Engineering.Perform steam-in-place temperature mapping activities.Conduct BI (biological indicator) handling, training, and retrieval activities.Review process data and coordinate with QC laboratories for report alignment.Generate execution records and complete all documentation in ValGenesis (e-validation platform).Equipment FocusLarge-scale cell culture systems (up to 20kL bioreactors)Downstream equipment including:Harvest clarification systemsViral filtration systemsUltrafiltration systemsBuffer transfer systemsTank farmsChromatography systemsSteam-based clean-in-place systemsDocumentation & ComplianceEnsure all execution activities follow GDP standards.Maintain strict adherence to GMP and validation best practices.Support compressed project timelines with multi-shift coordination.Collaborate cross-functionally with Engineering, Manufacturing, and Quality teams to ensure successful system turnover.Required Qualifications4–7 years of CQV experience in pharmaceutical or biologics manufacturing.Strong hands-on experience with process equipment qualification (IQ/OQ).Proven experience in downstream biologics equipment validation.Experience working in large-scale cell culture environments.Familiarity with steam systems, SIP/CIP processes, and flow path verification.Experience executing protocols in ValGenesis or similar e-validation platforms.Strong understanding of GDP and GMP documentation practices.Ability to work independently while maintaining alignment within a team structure.Comfortable working onsite in a fast-paced, time-sensitive environment.Preferred ExperienceExperience with compressed validation schedules.Exposure to facility expansions within existing GMP environments.Strong technical troubleshooting skills during equipment installation and commissioning.