GTO Technical Lead Process Engineer

Biopharma Asia; Nijmegen; Remote; EUR 76,000 - 121,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson in Nijmegen, Netherlands, seeks a senior process engineer to advance manufacturing processes and equipment development for medical devices. You will lead cross-functional teams, apply DOE and statistical methods, and ensure quality and regulatory compliance across projects.

The role requires 8–10 years in process/quality settings, strong leadership, and experience with GMP/QSR and lean tools. An international, collaborative environment is offered.

Qualifications

• BS in an engineering discipline with 8–10 years of related experience
• MS/PhD with 8+ years in process/equipment development for medical devices
• Strong communication and project management skills
• Experience leading multi-facility capital projects

Responsibilities

• Own technology platforms and represent the plant in multisite forums
• Lead multifunctional teams on projects and process improvements
• Mentor engineers and drive technical leadership
• Resolve complex technical issues using DOE and advanced statistics
• Manage large-scale capital programs across functions
• Develop innovative technology and guide plant strategy across platforms

Skills

Process Engineering

Lean Manufacturing

Statistical Methods

CAPA

Project Leadership

Education

Bachelor of Science in Engineering

MS or PhD in Engineering

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:

Nijmegen, Netherlands

Job Description:

JOB SUMMARY

Provides process engineering and controls support plans and conducts activities related to the development of new processes including researching current and emerging technologies, evaluating process cost, quality, and capability alternatives, and performing process characterization and optimization using design of experiments, problem solving and decision-making tools. Provides technical expertise in troubleshooting, design, and construction of manufacturing processes, systems and equipment. Plans, coordinates, documents, and implements all qualification and validation activities of new or improved manufacturing processes equipment and processes. Ensures fulfillment of all regulatory, safety, industrial hygiene and environmental requirements for implementation of new products, processes, and equipment. Provides technical expertise in advanced engineering, design, and construction of manufacturing facilities, systems, and equipment; and providing engineering and technical support for complex production and processing equipment.

DUTIES & RESPONSIBILITIES

• Owns a technology platform and may be required to represent the plant in multisite forums.
• Provides leadership across multifunctional teams on projects and process improvements as required.
• Leads and mentors Engineers on subject matter of expertise and related technical and leadership skills.
• Leads the resolution of complex technical issues in area of expertise, applying advanced statistical techniques, design of experiments and/or novel methods to drive successful outcomes.
• Manages large scale capital programs across multiple disciplines and/or functions.
• Develops innovative technology and sets direction in terms of the plant’s strategy for assigned platforms.
• Champions Engineering programs and best practices across multiple workstreams.
• Responsible for communicating business related issues or opportunities to next management level
• Interfaces with other plant locations such as Corporate and external vendors to ensure that the facility’s goals, objectives and requirements are met: included are project schedules and product/process requirements.
• Develops business cases for new technology introduction and provides input to the plant’s technology strategy.
• Prepares, discusses, documents, sets goals and measures above activities.
• Interfaces directly with Business Unit Managers/Staff Managers to ensure that manufacturing operations are projects receive effective technical support.
• Keeps Manager well informed of all major problems, improvement activities and potential barriers.
• Represents Ethicon Company during internal, J&J Corporate and FDA audits.
• Review preparation of strategies, protocols, data collection, data analysis and presentation, completion reports and document change package preparation.
• Serve as the process technical expert for one area within the plant.
• High degree of initiative required resolving unusual processing problems. Must be proactive and exercise good planning to accomplish Department and Company goals.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

• Bachelor Science (BS) Degree or Equivalents Bachelor’s degree in Engineering Discipline; BSME, BSChE, BSEE, preferred or equivalents Bachelor’s Degree.
• BS Degree or Equivalent with 8-10 years or more related experience.
• MS or PHD in Engineering Discipline with 8 plus years of work experience in the development of process and or equipment for medical device manufacturing. Proven track record in end to end development.
• Excellence communication and interpersonal relation skills.
• Experience in leading and managing projects and milestones preferred.
• Desire practical, first‑hand experience successfully applying lean manufacturing tools with documented improvement project completion.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Prefer Six Sigma Green Belt or Black Belt certification or equivalent.
• Knowledge of 21CFR 820, 21 CFR 4 and ISO 13485/EN ISO 13485.
• Knowledge of Statistical and analytical problem‑solving methodologies.
• Prefer knowledge of lean manufacturing and manufacturing processes.
• Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs).
• Ability to initiate and manage change as well as build effective teams across manufacturing and support areas in multiple facilities.

Required Skills:

Preferred Skills:

Agile Decision Making, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Research

The anticipated base pay range for this position is:

€76.000,00 - €121.440,00

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.

Additional information:

The Netherlands: 8%.The annual base pay includes an 8% holiday allowance.

Het bruto jaarsalaris is inclusief vakantietoeslag van 8%.