Vial Filling Process Manager; 2nd Shift

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.

• 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.

• 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.

• 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.