Process Validation Engineer

Reporting to the Senior Manager process Validation, the Process Validation Engineer IV is accountable for guiding teams and performing validation activities such as Performance Qualification (PQ), Process Validation (PV) and Revalidation (RV) in support of cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. These Process Validation activities include working with clients to define process control parameters and design protocols to test and verify process robustness. The role requires audit and inspection management support. In collaboration with validation management, assist internal project teams and external validation firms on Validation/qualification initiatives and to ensure project schedules are met. Complies with Health and Safety mandates and OSHA requirements. The PV Engineer IV will contributes and promotes a positive and equitable working environment emphasizing the Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. This position will support the process validation management in helping to train and mentor less experienced process validation Engineers. The role may also require supporting internal/external audits and other lifecycle activities to support the process validation program.