Director, System Owner Lead

Johnson & Johnson•Wilson, NC

4d•Onsite

About The Position

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 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 humanity. Learn more at https://www.jnj.com 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 Are you interested in joining a team which provides innovative workplaces and delivers outstanding site solutions to our enable our J&J Enterprise to better serve our patients and customers? Apply now for this exciting role! As part of the Global Process Engineering team, the Director, System Owner Lead 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.

Requirements

Minimum of a Bachelor's Degree in engineering required (Mechanical or Chemical Engineering preferred), MS or MBA preferred.
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

Nice To Haves

Consistent track record on leading capital projects in the range of 100 – 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.

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 influencing 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