System User, Device Assembly and Packaging (DAP)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 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.

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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.

Learn more at 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.

Key Responsibilities:

• Participation in all safety related reviews (HAZOP machine safety ergonomic safety)

• Review and approval of all User Requirement Specifications. (URSs)

• Review the deliverables from concept refresh basis-and detailed engineering (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)

• 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 (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 Bachelors or higher degree in Life Sciences Pharmacy or Engineering is required; a Masters or higher degree is preferred.

Experience and Skills:

Required:

• A minimum of 8 years of experience in the pharmaceutical industry including people leadership is required.

• A minimum of 3 years of experience in Device Assembly and Packaging of parenteral filled products

• 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 willing to take calculated risks 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 .

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 internal employees contact AskGS to be directed to your accommodation resource.

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