Vial Filling Process Manager (2nd Shift)
Scorpion Therapeutics
Main Responsibilities Oversee shift personnel and operations to ensure adherence to +QDCI standards. Lead and schedule shift operations using eOOE, iObeya, Qualipso, SAP, and Ocularis. Execute critical analyses and reviews (5W2H, Gembas, MSVs, LSVs), real-time reviews, BFRs, and audits. Investigate deviations from planned outcomes and develop robust Corrective and Preventive Actions (CAPA). Identify and lead continuous improvement projects to enhance performance and reduce waste. Coordinate cross-functionally to align priorities and achieve +QDCI standards. Support PCU development through coaching, training, and professional growth activities. Key Accountabilities Safety: Enforce safety procedures; conduct LSVs/MSVs; report incidents; participate in walkthroughs and investigations. Quality: Ensure cGMP compliance; lead 5W2H/deviation meetings; develop CAPAs; conduct real-time reviews. Delivery: Use data to drive performance improvements; support production flexibility; follow escalation procedures; review eOOE metrics; ensure timely training. Cost: Drive CI and cost reduction; minimize deviations; improve operator efficiency; support changeover functions. Qualifications Bachelor’s degree in Life Sciences, Engineering, or related field with relevant manufacturing/filling experience and 3+ years in pharmaceutical manufacturing/development.OR 7+ years relevant experience in manufacturing/filling biological products. 3+ years experience in pharmaceutical manufacturing/development. Prior FDA-regulated industry experience (required) and working knowledge of cGMPs (required). Aseptic processing experience strongly preferred. Skills/Competencies Detail-oriented; strong time management; strong analytical/problem-solving. Excellent communication and interpersonal skills; ability to work with all organizational levels. Intermediate MS Office; SAP knowledge preferred; Lean principles and mechanical/engineering competency preferred. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 1 day ago
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