Johnson & Johnson Innovative Medicine · 8 hours ago
Director, System Owner Lead
Wilson, NC
Full-time
Onsite
Director/Executive
15+ years expJohnson & Johnson is a leader in healthcare innovation, committed to improving health outcomes through advanced solutions. The Director, System Owner Lead will provide leadership in process engineering for a new aseptic manufacturing site, ensuring compliance with industry standards and overseeing technical aspects of project execution.
Pharmaceuticals
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
Qualification
Required
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
Preferred
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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
Company data provided by crunchbase