GTO Technical Lead Process Engineer

Leiden Bio Science Park; Nijmegen; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Health programs

Service recognition awards

Holiday pay included

Job summary

Ethicon seeks a senior process engineer to lead development and validation of new manufacturing processes and equipment. You will drive DOE-based optimization, mentor engineers, and coordinate cross-functional teams to ensure regulatory and quality compliance.

You will manage large capital programs, develop technology platforms, and interface with corporate and vendors to meet plant goals. Strong communication and leadership are essential.

Qualifications

• Bachelor's degree in Engineering required; BSME/BSChE/BSEE preferred or equivalent.
• 8–10 years of related experience in process/equipment development for medical devices.
• MS or PhD in Engineering with 8+ years experience in process/equipment development.
• Excellent communication and interpersonal skills.
• Experience leading projects and milestones.
• Practical experience applying lean manufacturing tools with documented improvements.
• Six Sigma Green Belt or Black Belt preferred.
• Knowledge of 21CFR 820, 21 CFR 4 and ISO 13485/EN ISO 13485.
• GMPs and Quality System Regulations (QSRs) knowledge.
• Ability to initiate and manage change and build effective teams across facilities.

Responsibilities

• Provide process engineering and controls support for new processes and equipment.
• Plan, coordinate, document and implement qualification/validation activities.
• Ensure regulatory, safety, IH and environmental requirements compliance.
• Offer technical expertise in design/construction of facilities, systems and equipment.
• Lead and mentor engineers; drive complex technical issue resolution using DOE/stats.
• Manage large-scale capital programs across disciplines.
• Develop technology platforms and plant strategy for assigned platforms.
• Interface with BU Managers and external vendors to meet goals.
• Communicate business issues/opportunities to management levels.

Skills

Process engineering

Controls engineering

Design of experiments

Statistical analysis

Problem solving

Leadership

Mentoring

Lean manufacturing

Six Sigma Green Belt

Six Sigma Black Belt

Regulatory awareness

Education

Bachelor's degree in Engineering

MS or PhD in Engineering

Tools

Quality systems knowledge (GMP, QSR)

Job description

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.

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.

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.

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.

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.

• 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.
• 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.
• Service anniversary and recognition awards.
• Subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans.
• The annual base pay includes an 8% holiday allowance.

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.

Knowledge of 21CFR 820, 21 CFR 4 and ISO 13485/EN ISO 13485.