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.

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.