Biologics Process Engineering Lead, Global Manufacturing

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 83,000 - 144,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking an experienced engineer to apply deep technical expertise at the intersection of manufacturing technology, operations, and business strategy in biologics drug substance GMP manufacturing.

As a Global Process Engineering SME, you will serve as the primary technical authority for complex production systems, facilitating technology transfer, new technology introduction, and strategic manufacturing initiatives across a global network.

Qualifications

• Bachelor's degree or equivalent; 8+ years in GMP biologics process/plant engineering.
• Experience in green or brown field GMP manufacturing startup including process systems, automation, utilities and facilities.
• Ability to lead multiple projects, define technical direction, and drive programs across complex portfolios.
• FPX certification and Six Sigma/Lean experience are a plus.

Responsibilities

• Serve as Process Engineering Domain Expert for Biologics Drug Substance Manufacturing, providing integrated engineering expertise with an operational focus.
• Provide technical leadership for technology transfer and new technology development projects; translate challenges into actionable solutions.
• Develop and maintain engineering standards, design guides, and best practices for biologics manufacturing processes and equipment.
• Lead cross-functional teams across projects, ensuring alignment with regulatory expectations (FDA/EMA) and corporate standards.
• Engage with external partners, industry consortia, and vendors to drive innovation and capability.

Skills

Agile decision making

Coaching

Cross-functional collaboration

Technical credibility

Technical leadership

Education

Bachelor's degree or equivalent University Degree

Tools

Six Sigma

Lean

Job description

Johnson & Johnson Innovative Medicine is seeking an experienced engineer to apply deep technical expertise at the intersection of manufacturing technology, operations, and business strategy in biologics drug substance GMP manufacturing.

As a Global Process Engineering SME, you will serve as the primary technical authority for complex production systems, facilitating technology transfer, new technology introduction, and strategic manufacturing initiatives across a global network.