Sr. Princ. Process Engineer – DP Aseptic Biotherapeutic Filling Equipment

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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 endtoend process engineering leadership for the design implementation and startup of stateoftheart 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 startup. The role offers the opportunity to influence critical technical decisions partner closely with crossfunctional teams and vendors and ensure the delivery of compliant highperforming filling systems that meet global regulatory expectations and support longterm business success.

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. EBeam isolators vial and syringe filling lines) in close collaboration with equipment suppliers and crossfunctional 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 startup of aseptic filling systems.

• Lead technical issue investigation and resolution during C&Q and startup ensuring systems are fully ready to enter qualification and routine operation.

• Drive coordination and execution across multiple functionsManufacturing Facilities MSAT Quality Procurement Engineering & Property Services (E&PS) and EHSto 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 datadriven insights and market intelligence to inform technical decisions optimize system performance and support longterm portfolio and facility strategy.

• Ensure all work follows company policies cGMP requirements global regulatory standards and customer specifications.

Qualifications

Education:

• Minimum of a Bachelors Degree in engineering required (Mechanical Engineering preferred) MS or MBA preferred.

Experience and Skills:

Required:

• Minimum of 10 years of process engineering and/or capital project execution experience supporting aseptic filling systems for largemolecule 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).

• Handson experience leading the design installation commissioning qualification (C&Q) and startup of aseptic filling line systems including isolatorbased 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 crossfunctional 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 problemsolving skills with the ability to resolve sophisticated process equipment and regulatory challenges during project execution and C&Q.

Solid understanding of:

• Aseptic processing and contamination control strategies

• Commissioning & Qualification methodologies

• Engineering design principles for biotherapeutic drug product facilities

• Construction and procurement processes

• Project controls and project scheduling

• EHS requirements including EHSbydesign and construction safety

• Excellent communication leadership and decisionmaking skills with the ability to influence stakeholders and drive alignment in a fastpaced evolving business environment.

• Strong passion for technical excellence and continuous improvement with the ability to drive innovation in aseptic filling equipment and facilities.

Preferred:

• Consistent track record leading largescale capital projects for aseptic filling systems with total project values in the range of $50M$100M.

• Experience supporting greenfield and/or brownfield GMP drug product manufacturing facility startups.

• Experience transitioning filling systems from conceptual design through operational readiness in a commercial biotherapeutic environment.

Other:

• This position will be located 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 plant site of Wilson NC.

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