Sr Principal Process Engineer

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

Leiden, South Holland, Netherlands

Job Description

About the Role

This role offers a compelling opportunity for an experienced engineering professional to apply deep technical expertise at the intersection of manufacturing technology, operations, and business strategy in biologics drug substance GMP manufacturing. As an SME in Global Process Engineering, you will serve as a primary technical authority for complex production systems, processing equipment, and manufacturing facilities — providing integrated engineering expertise with a strong operational focus across a global manufacturing network.

You will synthesize manufacturing challenges, business requirements, and technology inputs into integrated solutions that support technology transfer, new technology introduction, and strategic manufacturing projects. You will leverage internal expertise, and external partnerships to drive innovative engineering solutions and build technical capability across the organization.

This role requires strong technical leadership, effective cross-functional collaboration, and the ability to engage credibly with internal stakeholders and external partners alike — all in support of manufacturing projects that deliver real business and patient impact.

Key Responsibilities

• Serve as Process Engineering Domain Expert for Biologics (Biotherapeutics) Drug Substance Manufacturing, providing integrated equipment, utility, and facility engineering expertise with an operational focus to support J&J current internal manufacturing, CMO and strategic CAPEX projects
• Provide technical leadership for technology transfer and new technology development projects, translating complex engineering and manufacturing challenges into actionable business solutions
• Develop integrated business solutions for new technology strategies, site analysis, production network analysis, and strategic manufacturing initiatives
• Provide technical expertise and due diligence support for licensing, acquisition, network strategy, and technology strategy projects
• Develop, maintain, and continuously improve engineering standards, design guides, and best practice documents for biologics drug substance manufacturing processes and equipment
• Identify, evaluate, and champion emerging technologies and industry trends to advance manufacturing capabilities and maintain competitive advantage across the J&J network
• Ensure engineering designs and technology solutions comply with global regulatory expectations (FDA, EMA, and other health authorities) and current industry standards
• Lead multi-functional teams across projects and process improvement initiatives, resolving inter-functional issues and collaborating with manufacturing, quality, and engineering partners to define standards and project priorities
• Contribute to and leverage internal technical communities of practice to drive consistency and innovation across global manufacturing sites
• Engage with industry consortia, academic institutions, and technology vendors to stay at the forefront of biologics manufacturing technology and bring external innovation into J&J
• Contribute to long-range technology roadmaps and manufacturing network strategies, providing engineering input to inform capital investment decisions and site capability planning

Requirements

• Minimum of a Bachelor's or equivalent University Degree required;
• A minimum of eight (8) years of process/plant engineering experience in GMP MFG large molecule biologics facilities, drug substance preferred.
• Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities and operations.
• Strong technical background in Process and Manufacturing engineering, strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions Operational and financial fundamentals
• The ability to lead and/or support multiple projects simultaneously
• Defines technical or scientific direction of programs composed of multiple complex projects
• Engineers new and modifies existing processes to ensure right first time process start up
• Track record of successful program execution and team outcomes
• Excellent communication skills in English
• FPX certification and Six Sigma and/or Lean experience are a plus

Other

• This position may require up to 25% of domestic or international travel based on project business needs

Required Skills

Preferred Skills:

Agile Decision Making, Coaching, Consulting, Corrective and Preventive Action (CAPA), Crisis Management, Cross-Functional Collaboration, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility, Technical Research

The Anticipated Base Pay Range For This Position Is

€82.900,00 - €144.210,00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.