Senior Manager, Device Assembly & Packaging

jj

Charlotte (NC)

On-site

USD 150,000 - 210,000

Full time

3 days ago

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Job summary

Johnson & Johnson in Wilson, North Carolina, seeks a Senior Production Manager for Device Assembly and Packaging (DAP) within a greenfield aseptic Drug Product facility. You will lead design, start‑up, qualification, and routine operations while partnering with parenteral DP sites, engineering, quality, automation, MSAT, and supply chain teams.

The role requires 8+ years in pharma with sterile DP leadership and 3–5 years as DAP SME, plus strong knowledge of aseptic processing and cGMP

Qualifications

A Bachelor’s or higher degree in Life Sciences, Pharmacy, or Engineering is required; a Master's or higher degree is preferred.
A minimum of 8 years of experience in the pharmaceutical industry, with demonstrated technical leadership in sterile Drug Product manufacturing environments
A minimum of 3–5 years of hands‑on experience serving as a Subject Matter Expert in Device Assembly and Packaging (DAP) for aseptically filled parenteral products
Strong working knowledge of aseptic processing principles, contamination control strategies, and sterile manufacturing requirements, including barrier technologies
Proficiency with automated, digital, and robotic DAP systems used in sterile Drug Product manufacturing, with the ability to translate technology into compliant and efficient operations.

Responsibilities

Serve as the Device Assembly and Packaging (DAP) Subject Matter Expert for the design, start‑up, commissioning, qualification, and routine operation of an aseptic Drug Product manufacturing facility
Provide technical and operational leadership to ensure DAP processes, equipment, and systems comply with cGMP, aseptic processing requirements, and global regulatory expectations.
Author, review, and approve User Requirement Specifications (URS) and ensure alignment with aseptic processing strategy, device assembly needs, packaging requirements, and product quality attributes.
Review and approve engineering deliverables across project phases, including Process Flow Diagrams (PFDs), P&IDs, functional design specifications, equipment specifications, automation strategies, and process descriptions specific to DAP and aseptic operations.
Act as a key contributor to aseptic processing design, including material and personnel flows, environmental controls, line segregation, barrier/isolator or RABS strategies, and contamination prevention measures related to DAP.
Collaborate closely with global parenteral DP sites, engineering partners, quality, automation, MSAT, and supply chain teams to ensure harmonization, best‑practice adoption, and successful project delivery.
Develop and implement operator training strategies, including qualification plans, technical training, aseptic behavior training, and knowledge transfer for DAP operations.
Review the deliverables from concept refresh, basis-and detailed engineering (e.g.: PFD’s , P&ID’s, process descriptions, functional design specifications, equipment specifications)
Writing and/or review of Process Support Operational documentation (Master Batch Records, SOP’s, WI’s)
Actively support all commissioning and qualification batches
Actively support cycle development, cleaning, and hold time studies
Preparation and execution review & approval of validation related qualification documents and the resourcing of execution of associated tasks
The identification of required spare parts in accordance with the approved spare part list for the support systems and liaise with relevant parties for their procurement.
Monitoring and ensuring all user requirements are met
Lead the development, review, and approval of process support operational documentation, including Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Work Instructions (WIs), and packaging/device assembly instructions.
Define spare parts strategies for DAP and associated support systems, ensuring availability, lifecycle management, and alignment with maintenance and reliability plans.
Ensure timely and accurate responses to information requests, regulatory questions, and audit inquiries related to DAP and aseptic manufacturing readiness.
Execute all responsibilities within approved project timelines and budgets, proactively identifying risks and mitigation strategies to support on‑time facility start‑up and commercialization readiness.