System User, Filling and Preparation

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.

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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
Job 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.

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Learn more and apply to this exciting new role!

As a part of this new team, this role will work in close cooperation with other parenteral DP sites in the J&J network and lead and implement the recruitment ramp-up plan within the project timelines and budget and actively support cycle development, cleaning, and hold time studies

Key Responsibilities:

• Participation in all safety related reviews (HAZOP, machine safety, ergonomic safety)
• Review and approval of all User Requirement Specifications. (URS's)
• Review the deliverables from concept refresh, basis-and detailed engineering (e.g.: PFD's , P&'s, process descriptions, functional design specifications, equipment specifications)
• Writing and/or review of Process Support Operational documentation (Master Batch Records, SOP's, WI's)
• Preparation and execution review & approval of validation related qualification documents and the resourcing of execution of associated tasks (water batch, engineering batch, aseptic process simulation, validation batches)
• 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.
• Generation and execution of the above-mentioned activities within budget and current schedule
• Monitoring and ensuring all user requirements are met
• Signed URS
• Timely answered requests from information forms
• A list of disposables and pricing information (if applicable)
• Operational documentation for all process support equipment
• A training plan for operators

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.
• Knowledge of Good Manufacturing Practice (GMP) regulations and a proven track record of successfully implementing and maintaining cGMP compliance is required
• Proficiency in understanding and applying digital and robotics technologies, with a commitment to staying updated with emerging tools and platforms
• Strong creative thinking skills and a track record of developing innovative solutions for complex challenges
• Excellent interpersonal skills, with the ability to work collaboratively in diverse, global teams.
• Adept at analyzing complex issues and formulating effective solutions in a constantly evolving environment.
• Willingness and ability to adapt to shifting job requirements and work environments.
• Capacity to handle stress and challenges effectively, promoting a healthy work-life balance.
• An approach that recognizes opportunities and is…