Sr. Princ. Process Engineer – DP Aseptic Biotherapeutic Automated Optical Inspection Equipment

Johnson & Johnson Innovative Medicine•Wilson, NC

3d•Onsite

About The Position

As part of the Global Process Engineering team, the Sr. Princ. Process Engineer serves as the recognized technical authority and Subject Matter Expert for manual and automated inspection equipment. This role is accountable for the end‑to‑end (E2E) process engineering ownership of manual and automated inspection equipment, from conceptual design, commissioning and qualification, and initial equipment start-up for commercial manufacturing. This role will be responsible for demonstrating their scientific, technical, and business expertise to develop the process/equipment, solve sophisticated equipment issues, optimize the process, lead commissioning and qualification activities and line start‑up and ensure compliance to regulatory standards.

Requirements

Minimum of a Bachelor's Degree in engineering required (Mechanical Engineering preferred), MS or MBA preferred.
Minimum of 10 years optical inspection process engineering and/or capital project execution experience within a large-molecule biotherapeutic cGMP environment.
Strong background in aseptic, large-molecule, biotherapeutic drug product optical inspection principles
Experience leading optical inspection process engineering activities across the full project lifecycle, preferably within a capital project execution environment.
Proven track record of developing and sustaining strong partnerships with key stakeholders, serving as a trusted technical authority across Engineering, Manufacturing, MSAT, Quality, Facilities, E&PS, Procurement, EHS, and project leadership.
Demonstrated ability to lead, influence, and motivate multicultural and geographically dispersed teams, including internal teams and external partners, within a matrixed capital project environment.
Extensive experience interacting with external partners (A&E firms, construction contractors, system integrators, and equipment vendors) to define technical requirements, develop execution strategies, and deliver project objectives as the Optical Inspection (OI) Subject Mater Expert and technical lead.
Strong problem‑solving and conflict‑resolution skills, with the ability to address technical, schedule, and stakeholder challenges using sound engineering judgment and risk‑based decision making.
Deep understanding of complex technical and regulatory requirements impacting cGMP facility and equipment design, with the ability to translate regulatory expectations into compliant, practical, and scalable system solutions.
Demonstrated familiarity with technology advancements in vial, cartridge, and syringe container closure systems, particularly as applied to sterile, injectable biotherapeutic drug products.
Solid Understanding of the Following: cGMP requirements for optical inspection (manual and automated) in aseptic, large‑molecule biotherapeutic drug product commercial manufacturing.
EHS requirements, with a strong focus on EHS‑by‑design principles and construction safety throughout capital project execution.
Start‑up, commissioning, and qualification (C&Q) processes for automated optical inspection equipment, including system readiness and inspection performance verification.
Engineering design principles for biotherapeutic drug products, including aseptic processing, sterile manufacturing, optical inspection, and regulatory compliance considerations.
Construction and procurement processes, including vendor management, equipment procurement, and contract execution within capital projects.
Project controls and project scheduling methodologies, with the ability to support integrated project plans and milestone-driven execution.
Strong technical process engineering expertise, coupled with a demonstrated passion for solving highly complex, high‑impact technical challenges.
Excellent problem‑solving, communication, and decision‑making skills, enabling effective leadership in a fast‑paced, evolving business and project environment.
Proven ability to drive process engineering innovation for equipment and facilities, ensuring technical knowledge is sustained, expanded, and embedded across the organization.

Nice To Haves

Consistent track record leading large‑scale capital projects for optical inspection equipment with total project values in the range of $20M–$100M.
Experience supporting greenfield and/or brownfield cGMP drug product manufacturing facility start‑up in the area of optical inspection (manual and automated).
Experience transitioning OI equipment from conceptual design through operational readiness in a commercial biotherapeutic drug product environment.

Responsibilities

Act as the senior technical leader and Optical Inspection (OI) equipment owner, providing direction and oversight to internal teams and external partners (A&E firms, construction contractors, system integrators, and equipment vendors) to define scope, set expectations, and execute project strategies.
Demonstrated deep background and hands‑on expertise in optical inspection technologies, processes, and equipment within a cGMP, aseptic, large‑molecule biotherapeutic drug product environment.
Proven track record in leading the design, development, and implementation of manual and automated optical inspection processes and equipment, including recipe development and test kit design, supporting large-molecule, biotherapeutic aseptic drug products.
Strong capability to develop and deliver automated inspection equipment specifications and engineering documentation, including User Requirements Specifications (URS), data sheets, technical specifications, P&IDs, and PFDs, aligned with aseptic processing and sterile manufacturing requirements.
Accountable for vendor evaluation and selection, including assessing vendor capabilities, reviewing bid packages, and ensuring performance expectations are met through project.
Demonstrated leadership in factory and site acceptance testing (FAT/SAT), commissioning, qualification (C&Q), and start‑up, ensuring systems are inspection‑ready and compliant with regulatory requirements.
Ability to resolve complex technical issues during design, installation, and C&Q phases, applying strong problem‑solving skills and sound engineering judgment on OI equipment.
Experience leading cross‑functional collaboration with Manufacturing, MSAT, Quality, Facilities, E&PS, Procurement, EHS, and external partners, acting as the primary technical authority for the OI equipment.
Solid understanding of EHS‑by‑design principles, construction safety requirements, and project execution processes in cGMP environments.
Ability to apply data‑driven insights, industry benchmarking, and technology trends to influence design decisions and continuously improve inspection system performance.
Demonstrated leadership skills to mentor, influence, and guide diverse and multicultural teams, ensuring technical knowledge is maintained and expanded across the organization.