Senior Manager, Drug Product Filling & Preparation System User
Johnson & Johnson Innovative Medicine•Wilson, NC
•Onsite
About The Position
As part of a newly formed, high‑impact team, this role will collaborate across the J&J parenteral Drug Product (DP) network to shape and execute the site’s recruitment ramp‑up strategy and launching a world‑class aseptic manufacturing operation. This role will transition from a single contributor role into a Senior Production Manager role with responsibility for the filling/preparation operations team.
Requirements
- A minimum of 8 years of experience in aseptic operations (filling and preparation such as washing, autoclaving) in the pharmaceutical industry, including people leadership, is required.
- In-depth knowledge of Good Manufacturing Practice (GMP) regulations and a proven track record of successfully implementing and maintaining cGMP compliance
- Proficiency in understanding and applying digital and robotics technologies, with a commitment to staying current with emerging tools and p
- Strong creative thinking skills and a demonstrated ability to develop innovative solutions to complex challenges
- Excellent interpersonal skills, with the ability to collaborate effectively across diverse, global teams
- Demonstrated capability to analyze complex issues and formulate effective solutions in a rapidly evolving environment
- Willingness and ability to adapt to changing job requirements and work environments
- Proven capacity to manage stress and challenges effectively while promoting a healthy work–life balance
- A proactive, opportunity-oriented mindset that embraces calculated risk-taking and encourages entrepreneurial thinking
Nice To Haves
- Lean/Six Sigma certifications
Responsibilities
- Serve as Subject Matter Expert (SME) in aseptic operations, including filling and preparation activities such as washing, autoclaving, and associated support processes, within the pharmaceutical manufacturing environment
- Participation in all safety-related reviews (HAZOP, machine safety, ergonomic safety)
- Review and approval of all User Requirement Specifications (URSs)
- Review engineering deliverables from concept refresh, basis, and detailed engineering phases (e.g., PFDs, P&IDs, process descriptions, functional design specifications, equipment specifications)
- Writing and/or review of Process Support operational documentation (Master Batch Records, SOPs, WIs)
- Preparation, execution, review, and approval of validation and qualification documentation, including resourcing and execution of associated activities (water batches, engineering batches, aseptic process simulations, validation batches)
- Identification of required spare parts in accordance with approved spare parts lists for process support systems and coordination with relevant stakeholders for procurement
- Generation and execution of assigned activities in alignment with approved budgets and project schedules
- Monitoring and ensuring all user and regulatory requirements are met throughout the project lifecycle
- Management of signed URSs and timely response to requests for information
- Development of lists of disposables and associated pricing information (as applicable)
- Ensure availability and accuracy of operational documentation for all process support equipment
- Development and implementation of operator training plans for aseptic processing and support systems
Benefits
- inclusive work environment
- respect the diversity and dignity of our employees and recognize their merit
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What This Job Offers
Job Type
Full-time
Career Level
Senior
