GTO Technical Lead Process Engineer

Johnson & Johnson Co.; Netherlands; On-site; EUR 76,000 - 121,000; Full time

Job summary

Johnson & Johnson in the Netherlands is seeking a Senior Process Engineer to lead process development and qualification for new and improved manufacturing systems. You will drive DOE studies, problem solving, and CAPA to optimize cost, quality, and capability while ensuring regulatory and environmental compliance.

The role involves coordinating validation activities, mentoring engineers, and interfacing with multiple plants and vendors.

Qualifications

• Bachelor's degree in engineering discipline required.
• MS or PhD in engineering preferred with 8+ years in process development.
• Lean manufacturing and GMP/QSR knowledge beneficial.

Responsibilities

• Leads cross-functional teams on process improvement projects.
• Manages large capital programs across disciplines.
• Develops and implements validation activities for new processes.
• Represents a plant during internal, corporate and regulatory audits.

Skills

Process engineering

Design of experiments

Statistical analysis

Lean manufacturing

CAPA

Project management

Education

Bachelor of Science in Engineering

MS or PhD in Engineering

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

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%.

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 https://www.jnj.com/.

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.