Director, Aseptic DP Process Engineering

Johnson & Johnson Innovative Medicine•Wilson, NC

1d•Onsite

About The Position

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.

Requirements

A 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 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)

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

Benefits

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 jnj.com.
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.
Learn more at https://www.jnj.com/innovative-medicine
Learn more and apply to this exciting new role!
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.