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Job Function:
Supply Chain EngineeringJob Sub Function:
Process EngineeringJob Category:
People LeaderAll Job Posting Locations:
Wilson, North Carolina, United States of AmericaJob Description:
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As part of the Global Process Engineering team, the Director, Aseptic DP Process Engineering, is the technical expert and will provide overall E2E process engineering leadership to equipment and facility design of a new DP aseptic manufacturing node. They will be accountable for all technical aspects of process engineering areas (warehouse, laboratories, clean utilities, preparation, compounding/filling, optical inspection, and device assembly and packaging) ensuring the efficient design and operational readiness and start-up of the new site in compliance to cGMP and industry standards.
Key Responsibilities:
- Development and delivery of all process engineering specifications (user requirements, data sheets, technical specifications
- Assess vendor competency and capabilities, review and discuss bid documents, and be held accountable for project development and execution, including performance of the process systems
- Technical issue resolution on the system during C&Q testing and the readiness of the system to start C&Q activities
- Helping to identify and expedite key activities across multiple business functions (Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS (Engineering & Property Services), and EHS
- Ensure alignment across evolving business needs and require strong partner management and leadership skills to collaborate across these multiple business partners.
- Maintaining a solid understanding of industry trends and benchmarking against internal/external practices
- Actively participate in inclusion initiatives to build a well-rounded, high performing engineering team
- Cultivate a culture of technical excellence, collaboration, and innovation to enable multi-functional learning and standard methodology sharing
- Develop and mentor engineering team members to ensure a strong talent pipeline
- Apply data-driven insights and market intelligence to advise future decision making, stay informed on industry and regulatory trends, and adapt strategies accordingly to achieve excellent portfolio performance.
- Ensure compliance with policies, procedures, government regulations, and customer specifications
- Collaborate with an engineering firm to advance the facility design
Qualifications
Education:
- Minimum of a Bachelor's Degree in engineering required (Mechanical or Chemical Engineering preferred), MS or MBA preferred.
Experience and Skills:
Required:
- A minimum 15 plus years in drug product experience in a biotherapeutics cGMP environment (preferably in process engineering or capital project execution)
- A minimum 5 plus years of people leadership experience
- Shown success in building and developing high performing team
- Track record of developing and maintaining strong partnerships at all levels within the organization, including key stakeholders
- Ability to lead and motivate multicultural teams and remote customers
- Excellent problem-solving skills when handling potential conflicts
- Understanding sophisticated technical/regulatory issues impacting facility/equipment design
Solid understanding of the following :
- cGMP’s for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment design
- EHS requirements, with particular focus on EHS by design and construction safety
- Start-up processes and Commissioning & Qualification
- Principles for Engineering Design for drug products in the Biotherapeutic industry
- Construction & Procurement process
- Project Controls processes
- Project scheduling
- Strong technical process engineering knowledge and experience and has a great passion for solving highly complex technical problems
- Strong problem solving, communication, and decision-making skills to drive impact in a fast-paced evolving business landscape
- Ability to drive process engineering innovation for equipment and facilities ensuring technical knowledge is maintained and expanded throughout the team
Preferred:
- Consistent track record on leading capital projects in the range of 250 – 500 MM$ (preferred)
- Strong process engineering expertise in conceptual design through C&Q (commissioning & qualification) to ensure efficient operational readiness within a biotherapeutic drug product environment.
- Leadership experience in a greenfield project(s)
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
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
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 Decision Making, Consulting, Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Inclusive Leadership, Leadership, Lean Supply Chain Management, Manufacturing Standards, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Schedule, Resource Planning, Science, Technology, Engineering, and Math (STEM) Application, Stakeholder Engagement, Technical ResearchSkills Required
- Bachelor’s degree in engineering; Mechanical or Chemical Engineering preferred
- 15 or more years of drug product experience in a biotherapeutics cGMP environment
- 5 or more years of people leadership experience
- Demonstrated success building and developing high-performing teams
- Track record of developing and maintaining strong organizational partnerships
- Ability to lead and motivate multicultural teams and remote customers
- Excellent problem-solving skills for resolving potential conflicts
- Understanding of complex technical and regulatory issues affecting facility and equipment design
- Knowledge of cGMP requirements for aseptic manufacturing across EU and FDA regulations, including EU Annex 1
- Knowledge of EHS requirements, including EHS by design and construction safety
- Knowledge of startup processes and Commissioning and Qualification
- Knowledge of engineering design principles for biotherapeutic drug products
- Knowledge of construction and procurement processes
- Knowledge of project controls and project scheduling
- Strong technical process engineering expertise and complex technical problem-solving ability
- Strong problem-solving, communication, and decision-making skills
- Ability to drive process engineering innovation for equipment and facilities
- Master’s degree or MBA
- Experience leading capital projects valued at $250 million to $500 million
- Process engineering experience from conceptual design through Commissioning and Qualification
- Leadership experience on greenfield projects
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
