Principal Process Engineer LabAdministration Bldg

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Wilson North Carolina United States of America

Job Description:

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 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 Principal Process Engineer Lab/Administration Bldg. will serve as the recognized technical leader and be responsible for the end-to-end process engineering related to the laboratory/administration building for a new biotherapeutic drug product plant. This role is responsible for leadership for the design implementation and start-up of the state-of-the-art laboratory/administration building. This role is responsible for ensuring systems remain fit for intended use aligned with business and compliance requirements and managed throughout their lifecycle in a manner that protects quality data integrity and continuity of operations. The position partners across laboratory operations quality commissioning & qualification environmental health and safety engineering and property services and manufacturing science and technology to support healthcare innovation through system governance user support training and continuous improvement.

Key Responsibilities:

• Serve as the designated process engineering lead for the biotherapeutic drug product plant laboratory and administration building design documents (User Requirement Specifications (URS) equipment data sheets room cards technical specifications P&IDs and process flow diagrams (PFDs)

• Evaluate and select equipment vendors by assessing technical capability reviewing bid packages and leading technical discussions maintain accountability for the biotherapeutic drug product (DP) laboratory/administration building performance through project execution

• Develop system procedures work instructions inventories training materials and other controlled documentation in accordance with engineering and quality system requirements.

• Partner closely with key stakeholders to ensure complaint and effective system operation

• Promote and support data integrity electronic records expectations audit trail review processes and good documentation practices across system use and administration.

• Coordinate vendor support and service requests during facility start-up activities to sustain performance compliance and user experience.

• Provide end-user support and training that enable consistent standardized and compliant system use across laboratory and administrative processes.

• Translate business needs into clear system requirements and contribute to process simplification standardization and continuous improvement initiatives.

• Support audits inspections and internal assessments by providing documentation evidence and domain expertise in a timely and accurate manner.

• Model inclusive collaboration and Credo-based decision-making while helping deliver solutions that support patients customers and colleagues through high-quality operations.

Qualifications

Education:

• Minimum of a Bachelors Degree in engineering required.

Experience and Skills:

Required:

• minimum of ten years of process engineering and/or capital project execution experience leading the design development of biotherapeutic drug product laboratories/administration buildings

• Hands-on experience leading the design installation commissioning and qualification (C&Q) and start-up of biotherapeutic drug product laboratories and administrative buildings

• Deep understanding of global aseptic manufacturing regulations including FDA cGMPs and EU Annex 1 and their impact on facility equipment and process design

• Shown ability to lead and collaborate across cross-functional teams (Manufacturing MSAT Quality Facilities EHS Procurement Engineering & Property Services and Automation) in a matrix environment.

• Strong technical problem-solving skills with the ability to resolve sophisticated process equipment and regulatory challenges during project execution C&Q and facility start-up

• Familiarity with GxP expectations data integrity principles electronic records/e-signatures audit trails and controlled documentation practices.

• Demonstrated attention to detail sound judgment and the ability to manage multiple priorities in a structured environment.

• A continuous improvement mindset and commitment to quality compliance and operational excellence

Core Competencies

• Credo-based accountability and integrity

• Quality and compliance focus

• Data integrity and risk awareness

• Technical aptitude and disciplined problem solving

• Cross-functional collaboration and communication

• Documentation excellence and organizational skills

• Continuous improvement and learning agility

• Inclusive mindset and respect for diverse perspectives

• Commissioning & Qualification methodologies

• Engineering design principles for biotherapeutic drug product facilities

• Construction procurement project controls and project scheduling

• Excellent communication leadership and decision-making skills with the ability to influence stakeholders and drive alignment in a fast-paced evolving business environment.

Preferred:

• Consistent track record leading large-scale capital projects for biotherapeutic drug product laboratory/administrative building design with total project values in the range of $50 to $750 MM

• Experience supporting greenfield and/or brownfield GMP drug product manufacturing facility start-ups.

• Experience transitioning the design of laboratory and administrative buildings from conceptual design through operational readiness in a commercial biotherapeutic environment.

• Experience with laboratory platforms such as LIMS ELN CDS instrument software or related enterprise applications is an advantage.

Other:

• This position will be 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 plate site in Wilson NC.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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 Business Savvy Coaching Corrective and Preventive Action (CAPA) Crisis Management Critical Thinking Disruptive Innovations Emerging Technologies Industrial Hygiene Lean Supply Chain Management Organizing Process Control Process Engineering Product Costing Program Management Project Schedule Science Technology Engineering and Math (STEM) Application Technical Research