Plan, coordinate, organize, and control production for manufacturing processesReview all production batch records and supplemental attachments for completeness, accuracy and compliance to cGMPInvolve in the set-up, formulation, fills, visual inspections, labeling and packaging of pharmaceuticals and medical devices of customers' productsMaintain and ensure facility compliance to cGMP, company and client SOPs, and legal regulationsPerform aseptic operations (formulation/filtration/fill) in Clean Rooms ISO Class 5, 7 and 8 areas and environmental monitoringExperience in weighing and dispensing Active Pharmaceutical Ingredients (API) and chemicalsIs aseptic gowning and aseptic/sterile filling qualifiedOperate Hull 24 and 48 Lyophilizer equipmentTrain and supervise a team of 6 on manufacturing activities