Senior Manager, Drug Product Optical Inspection System User

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn

more at  () .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

** Job Function:*
* Supply Chain Manufacturing

** Job Sub*
* ** Function:*
* Manufacturing Pharmaceutical Process Operations

** Job Category:*
* Professional

** All Job Posting Locations:*
* Wilson, North Carolina, United States of America

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* Job Description:

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* ** About Innovative Medicine*
* Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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Learn more and apply to this exciting new role!

As a member of this new team, the role will partner closely with parenteral Drug Product sites across the J&J network and will own and drive the end‑to‑end recruitment ramp-up strategy, delivering results in alignment with project timelines and budget commitments. This role will transition from a single contributor role into a Senior Production Manager role with responsibility for the Optical Inspection operations team.

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* Key Responsibilities:

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* + Serve as the recognized Subject Matter Expert (SME) for Optical Inspection across the Drug Product facility, providing end-to-end technical ownership for manual and automated visual inspection processes for parenteral products.

+ Lead and actively participate in all safety‑related reviews (HAZOP, machine safety, ergonomic and human-factors assessments), with specific focus on inspection systems, operator interfaces, and defect-handling risks.

+ Own the review and approval of User Requirement Specifications (URS) for optical inspection systems, ensuring alignment with cGMP, global regulatory expectations, inspector qualification requirements, and product quality standards.

+ Review and approve engineering deliverables from concept through detailed design (e.g., PFDs, P&IDs, functional design specifications, equipment and automation specifications), acting as the final technical authority for inspection-related decisions.

+ Define, govern, and continuously improve defect libraries, inspection standards, acceptance criteria, and inspection strategies, including challenge and approval of critical defect classifications and assumptions

+ Author, review, and approve process support and operational documentation, including Master Batch Records, SOPs, Work Instructions, inspection test kits, defect standards, and inspector qualification materials.

+ Provide active on-site support during commissioning, qualification, and validation activities, including engineering studies, water and engineering batches, aseptic process simulations (APS), and validation batches, ensuring inspection readiness and compliance.

+ Lead the preparation, execution, review, and approval of validation documentation related to optical inspection systems, including IQ/OQ/PQ, inspector qualification, and ongoing performance monitoring.

+ Act as the quality-facing SME during regulatory inspections, audits, and internal reviews, confidently representing inspection strategies, data integrity, and compliance posture, and driving resolution of complex inspection-related observations.

+ Ensure digitalization, automation, and robotics solutions for inspection are appropriately evaluated, selected,…