Director, Aseptic DP Process Engineering

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Wilson, North Carolina, United States of America

Job 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.

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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.

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 Research