Principal Process Engineer Lab/Administration Bldg

Johnson & Johnson•Wilson, NC

15h•Onsite

About The Position

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.

Requirements

Minimum of a Bachelor’s Degree in engineering 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.

Nice To Haves

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.

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.