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Job Function:
Supply Chain ManufacturingJob Sub Function:
Manufacturing Pharmaceutical Process OperationsJob Category:
ProfessionalAll Job Posting Locations:
Wilson, North Carolina, United States of AmericaJob Description:
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.
Learn more at https://www.jnj.com/innovative-medicine
Learn more and apply to this exciting new role!
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.
Key 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
Qualifications
Education:
A Bachelor’s or higher degree in Life Sciences, Pharmacy, or Engineering is required; a Master's or higher degree is preferred
Experience and Skills:
Required:
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
Preferred:
Lean/Six Sigma certifications
Other:
This position will be located in Wilson, North Carolina, and will require full time on-site support. However, the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson, NC.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agile Manufacturing, Business Intelligence (BI), Change Management, Chemistry, Manufacturing, and Control (CMC), Competitive Landscape Analysis, Consulting, Cost-Benefit Analysis (CBA), Developing Others, Gap Analysis, Good Manufacturing Practices (GMP), Industry Analysis, Manufacturing Standards, Operational Excellence, Organizational Knowledge, Organizing, Plant Operations, Process Optimization, Program Management, Technical Credibility