Sr. Princ. Process Engineer – DP Aseptic Biotherapeutic Filling Equipment
Johnson & Johnson MedTech · Wilson, NC
- Level
- Senior
- Team
- Process
- Travel
- 75%
- Degree
- Required
- Experience asked
- 10+ years
- Industry
- Medical devices
- Posted
- 16 days ago
The role in 30 seconds
A senior process role at Johnson & Johnson MedTech (medical devices) in Wilson, NC.
- They ask for
- 10+ years · degree required
- Tools it names
- FDA / GMP, Packaging lines, EHS / safety
- Day to day
- about 75% travel
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About the role
Key Responsibilities
- ◆Lead the development and delivery of aseptic filling line system documentation, including User
Requirements
Specifications (URS), equipment data sheets, 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 filling system performance through project execution.
- ✓Lead the detailed design and engineering of aseptic filling line equipment (e.g., E‑Beam, isolators, vial and syringe filling lines) in close collaboration with equipment suppliers and cross‑functional stakeholders
- ✓Own the layout, design, and integration of the filling line within the facility, ensuring alignment with aseptic processing, Annex 1 requirements, and operational needs.
- ✓Serve as the technical lead for FAT, SAT, (C&Q), and start‑up of aseptic filling systems.
- ✓Lead technical issue investigation and resolution during C&Q and start‑up, ensuring systems are fully ready to enter qualification and routine operation.
- ✓Drive coordination and execution across multiple functions—Manufacturing, Facilities, MSAT, Quality, Procurement, Engineering & Property Services (E&PS), and EHS—to remove barriers and maintain project momentum.
- ✓Provide strong technical leadership and partner management, ensuring alignment across evolving business, quality, and regulatory expectations.
- ✓Stay ahead of on industry trends, regulatory changes, and external guidelines, benchmarking internal designs and approaches against leading standards.
- ✓Apply data‑driven insights and market intelligence to inform technical decisions, optimize system performance, and support long‑term portfolio and facility strategy.
- ✓Ensure all work follows company policies, cGMP requirements, global regulatory standards, and customer specifications.
Education
- ✓Minimum of a Bachelor's Degree in engineering required (Mechanical Engineering preferred), MS or MBA preferred.
Required
- ✓Minimum of 10 years of process engineering and/or capital project execution experience supporting aseptic filling systems for large‑molecule biotherapeutic drug products (vials and/or prefilled syringes) in a cGMP drug product manufacturing environment.
- ✓Demonstrated experience as a technical lead or subject matter expert (SME) for aseptic filling operations for sterile injectable biologics (e.g., monoclonal antibodies, recombinant proteins, vaccines).
- ✓Hands‑on experience leading the design, installation, commissioning, qualification (C&Q), and start‑up of aseptic filling line systems, including isolator‑based filling technologies.
- ✓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) in a matrixed environment.
- ✓Extensive experience working with external partners (A&E firms, construction contractors, and equipment vendors) to develop, execute, and deliver complex capital projects.
- ✓Strong technical problem‑solving skills, with the ability to resolve sophisticated process, equi
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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 jnj.com .
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 https://www.jnj.com/innovative-medicine
Ready to lead at the forefront of aseptic filling innovation? Learn more and apply today!
As a part of the Global Process Engineering team, the Sr. Princ. Process Eng – DP Aseptic Biotherapeutic Filling Equipment will serve as a recognized technical leader and SME, playing a pivotal role in shaping the future of aseptic drug product manufacturing. This role owns end‑to‑end process engineering leadership for the design, implementation, and start‑up of state‑of‑the‑art aseptic filling line systems (vial and syringe) within a new cGMP manufacturing facility.
Using deep scientific, engineering, and business expertise, this leader will drive the development and optimization of filling system equipment, solve complex technical challenges, and guide systems from concept through commissioning, qualification, and successful line start‑up. The role offers the opportunity to influence critical technical decisions, partner closely with cross‑functional teams and vendors, and ensure the delivery of compliant, high‑performing filling systems that meet global regulatory expectations and support long‑term business success.