The RoleSupport GMP validation projects of low to medium complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resourcesOversee qualification activities in cGMP validation best practicesAs required, develop qualification and validation protocols, execute the associated studies, analyze the resulting data, and develop the final reportSupport validation deviation investigations and determine assignable cause alongside Validation Lead and contractorsReview validation lifecycle documentation, including requirements, specifications, protocols, and reportsSupport the Validation Team in any required activities to support the development, execution, or improvement of the Validation programUnderstand the application of Data Integrity per 21 CFR Part 11Experience and familiarity with the application of FDA, GLP, QSR, and cGMP regulationsEquipment qualification principles in a cGMP environment (IQ, OQ, PQ)Understanding of the validation lifecycle in GMP settingsKnowledge of cGMP, GAMP, 21CFR part 11, GDPKnowledge of pharmaceutical, manufacturing, and laboratory systems and equipmentThe CandidateBachelor's Degree with 1+ years of cGMP experience (Pharmaceutical, Life Sciences industry cGMP environment) Master's Degree is a plusExperience in the qualification of cell therapy equipment and cGMP environment is a plusExcellent interpersonal skills with experience dealing with a diverse workforceStrong multi‐tasking ability in conjunction with proven organizational skills. Able to quickly understand and learn new technologiesCreative in problem-solving abilities, able to think outside the box to find solutionsSelf-motivated and self-starter, able to work independently with minimal supervisionMust be proactive, results oriented, and have strong attention to detailStrong written and verbal communication skills (including technical writing skills)May be required to work in controlled or clean room environmentsOccasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting to 25lbs.