Validation Engineer

Position: Senior CQV Engineer – Fill Finish Systems (2 Openings)Location: Kansas (Onsite)Duration: ContractJob SummaryWe are seeking two experienced Senior CQV Engineers to support commissioning, qualification, and validation activities for a large-scale biopharmaceutical manufacturing facility. The ideal candidates will have strong experience with aseptic fill-finish systems and will lead CQV activities for critical manufacturing equipment, utilities, and processes while ensuring compliance with cGMP, FDA, EMA, and industry standards.Key ResponsibilitiesLead commissioning, qualification, and validation activities for fill-finish manufacturing systems.Develop and execute Validation Master Plans (VMPs), risk assessments, IQ/OQ/PQ protocols, and summary reports.Support technology transfer, new product introduction (NPI), process validation, and regulatory inspection readiness activities.Perform system impact assessments, change control evaluations, deviation investigations, and CAPA implementation.Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and Project teams to ensure successful project execution.Ensure compliance with GMP regulations, data integrity requirements, and validation best practices.Provide technical guidance and mentorship to junior CQV and validation personnel.Required Experience5+ years of CQV/Validation experience within pharmaceutical, biotech, or biologics manufacturing environments.Hands-on experience qualifying aseptic fill-finish equipment and processes.Strong experience executing IQ/OQ/PQ protocols and validation documentation.Knowledge of cGMP, FDA, EMA, ISPE, and industry validation standards.Experience supporting deviations, investigations, change controls, and CAPAs.Preferred Equipment ExperienceVial filling linesIsolatorsRestricted Access Barrier Systems (RABS)LyophilizersAutoclavesDepyrogenation tunnelsCappersVisual inspection systemsFilling linesPackaging linesCIP skidsPreferred QualificationsBachelor's degree in Engineering, Life Sciences, or a related technical discipline.Strong communication and cross-functional collaboration skills.Experience supporting large-scale facility startup, expansion, or capital projects.Ability to work independently in a fast-paced project environment.