Senior Biotherapeutic Logistics Process Engineer

Biopharma Asia; Wilson (NC); In loco; USD 140.000 - 200.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson in Wilson, North Carolina, seeks a Sr. Principal Engineer Process Engineer to own end‑to‑end logistics system design for large‑molecule biotherapeutics.

You will lead equipment selection, factory floor layouts, and cross‑functional collaboration to ensure seamless startup and compliant operations. You will coordinate with external partners, drive C&Q activities, and maintain alignment with Manufacturing, MSAT, Quality and EHS while advancing innovation in biotherapeutic

Competenze

• Minimum of 12 years logistics process engineering and/or capital project execution experience in a large‑molecule, biotherapeutic cGMP environment.
• Strong experience driving floorplan design for warehouse, material transport corridors, and in‑process storage areas through simulation modeling, process mapping, and time studies to maximize flow efficiency.
• Proven ability to build and maintain strong partnerships with cross‑functional stakeholders.
• Ability to lead and influence multicultural teams and remote collaborators.
• Extensive interaction with external partners (A&E firms, construction teams, and equipment vendors) as a logistics process engineer.
• Demonstrated strength in resolving complex technical and regulatory challenges impacting the equipment and facility design in logistics for large‑molecule, biotherapeutic products.
• Solid understanding of cGMP requirements for logistics of large‑molecule biotherapeutic products.
• EHS requirements, with emphasis on EHS‑by‑design and construction safety
• Start‑up processes and Commissioning & Qualification (C&Q) for a large‑scale biotherapeutic logistics operation
• Engineering design principles for biotherapeutic drug product manufacturing
• Construction, procurement, project controls, and project scheduling
• Strong technical depth, problem‑solving capability, communication skills, and decision‑making ability in a fast‑paced environment
• Passion for driving innovation in equipment and facility design

Mansioni

• Lead development and delivery of the logistics area, including specifications and drawings (URS, data sheets, technical specifications, P&IDs, PFDs) supporting large‑molecule, aseptic biotherapeutic drug product operations.
• Provide process system ownership and technical leadership for logistics equipment used in biotherapeutic drug product manufacturing.
• Assess vendor competency and capabilities; review and influence bid documents; and maintain accountability for project development and execution, including system performance.
• Lead detailed design and development of logistics equipment, collaborating with cross‑functional partners and strategic equipment vendors.
• Serve as the logistics SME for large‑molecule, aseptic drug product projects, interfacing with A&E firms, construction partners, and equipment suppliers.
• Lead and support equipment FAT, SAT, commissioning, qualification, and commercial production line start‑up activities.
• Resolve complex technical issues during C&Q and ensure system readiness for qualification and commercial operation.
• Partner closely with Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS, Automation, Inventory Management, Cold Chain, and EHS to align priorities and accelerate execution.
• Ensure alignment across evolving business needs, applying strong stakeholder and partner management skills.
• Maintain current knowledge of industry trends and biotherapeutic regulatory expectations
• Apply data‑driven insights and market intelligence to guide technical and strategic decisions
• Ensure full compliance with company policies, cGMPs, regulatory requirements, and customer specifications

Conoscenze

Logistics process engineering

Capital project execution

Cross-functional collaboration

Leadership

Remote collaboration management

Formazione

Bachelor’s degree in Engineering

Master’s degree or MBA preferred

Descrizione del lavoro

Johnson & Johnson in Wilson, North Carolina, seeks a Sr. Principal Engineer Process Engineer to own end‑to‑end logistics system design for large‑molecule biotherapeutics.

You will lead equipment selection, factory floor layouts, and cross‑functional collaboration to ensure seamless startup and compliant operations. You will coordinate with external partners, drive C&Q activities, and maintain alignment with Manufacturing, MSAT, Quality and EHS while advancing innovation in biotherapeutic