Wilson, North Carolina, United States of America, United States of America
Onsite
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Job Function:
Supply Chain EngineeringJob Sub Function:
Process EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Wilson, North Carolina, United States of AmericaJob 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 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 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 Bachelor’s 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 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.
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 ResearchWant to know if this job is worth applying to?
