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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

Job Function:

Supply Chain Engineering

Job Sub** **Function:

Process Engineering

Job Category:

People Leader

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

Johnson & Johnson is currently seeking a Director Process Engineering, Systems Owner Lead to join our MAKE Asset Management Organization located in US Large Molecule Drug Substance Site located in Wilson, North Carolina. This role will support a new site startup, as such it may require periods of heightened travel to support these activities. This travel would be during the site ramp up period and dependent on functional needs and project timelines (in some cases frequent travel and or short terms stays with vendors, sister companies, partners).

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be 25 %.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

The Director will build and develop a team of sought after, business savvy, process engineer talents and encourage a two-way capability exchange with partners. The Director and their team will interact with a variety of partners across Johnson and Johnson, but key partners includes E&PS, MSAT, QA and the local platform MAM teams. The system owner lead will also partner with external equipment vendors, and engineering firms. This individual is a full member of the Project Leadership Team and participates, drives, owns, shapes, and leads the strategy and execution together with the other PLT members.

Key Responsibilities:

+ Creating a future vision, gaining support and alignment to that vision, and driving strategic direction and deploying goals and objectives into meaningful actions

+ Accountable for accuracy and timely delivery of all process related activities from design to start-up.

+ Providing leadership for the system owners to ensure process engineering expertise are available and delivering the right level of support through detailed design, FAT, SAT, and Process Validation of BioNC.

+ Leading the engineering innovation and concept planning for equipment and facilities following MSAT’s product guidance

+ Responsible for a high functioning team of process and project engineers responsible for system ownership of the manufacturing process equipment and clean utilities for a multi-billion dollar project.

+ Collaborating closely with project engineering, construction management, PMO, C&Q and automation to ensure the user requirements are met through all phases of the BioNC project

+ Supporting site master plans with MAM’s support in alignment with the network strategy for Drug Substance Facilities.

+ Addressing any conflicts arising in the field and elevate any issues that require management input to the project management

+ Confirming issues are recorded on the Project punch list system, Field View (FV), and Managing outstanding punch list items through GT, and BT as well as support System Users throughout the Validation runs

+ Completing EHS&S by Design/PSSR checks with EHS&S

+ Coordinating owner side the Green Tag (GT) walk down and manage the check list

+ Signing off on the GT Approval Form and GT check list accepting that the system is ready for C&Q activities

+ Reviewing and approving of System Test Protocols (STP). The STP will be written by Sisk/PMG but the final responsibility lies with the System Owner

+ Evaluating if punch list items or incident are deemed design changes and elevate them to an Project Change Notice (PCN) if required

+ Post-execution approval of STPs (Blue Tag) and related Exception Forms and applicable System Test Reports (STRs)

+ Assisting in the turnover of the documentation for the process systems from Eng/Vendor to the J&J document system (review and approval of SDIs on applicable VTOPs and TTOPs)

+ Participate in problem and root cause identification, solution, proposals, action planning, and implementation of corrective measures, re-inspection, re-testing and documentation of satisfactory results

+ Supporting handover of Care Custody and Control from the project to the relevant J&J System User

+ Assisting the PQ team member in the qualification of the system

+ Assisting the functional leaders of Cleaning Validation, CSV and Packaging Validation developing, planning, executing and approving

+ Supporting the R&D Pharm Tech leader to develop and execute the process development, characterization and process performance qualification protocols for process validation

Qualifications

Education:

+ Minimum of a Bachelor's Degree focused in Chemical, Mechanical and/or Bioprocess Engineering is required.

Experience and Skills:

Required:

+ A minimum of ten (10) years of related work experience

+ Experience in synthesizing business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into data driven business solutions

+ Functional knowledge of/and experience in engineering, automation and maintenance of equipment and systems within Pharmaceuticals manufacture or other healthcare regulated sectors

+ Proven success in Building and developing an impactful teams

+ Working technical process engineering knowledge and experience, great passion for technical solutions of high complexity

+ Showing initiative in innovative approaches to challenges in a fast-paced, changing global environment

+ Excellent communication skills to summarize and effectively present a situation and related options, to build consensus

+ Experience in influencing and risk management to drive trade off decision making across the organization

+ Strong collaboration, and influencing skills to partner effectively across multiple groups and at all levels of the business

+ Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships and collaborate both internally and externally

+ Strong organization and prioritization skills

Preferred:

+ 20+ years of total proven experience

+ 10+ years of Process Engineering experience

+ 10+ years of Biologics experience

+ 5+ years of green field start-up experience

Other:

+ This position may require up to 25 % domestic and international travel.

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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: