Process Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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Position: Process Engineer (initially 1-year Fixed Term)

Report to: Engineering Manager

Location: Nijmegen Netherlands(Fully Onsite Role)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at of Role:

Under the direction of the Engineering Manager the Process Engineer provides technical leadership for manufacturing processes and equipment. This role supports cross-functional initiatives to improve safety quality yield throughput and capacity; drives robust change control and process validation/qualification; and supports structured problem solving to reduce deviations and prevent recurrence through effective CAPA.

Key Responsibilities:

• Identifying improvement opportunities and participating in project to enhance safety quality yield and efficiency.

• Monitoring and reporting key performance indicators (KPIs) for process performance equipment utilization downtime scrap and yield; drive actions based on performance and risk.

• Supporting manufacturing equipment and process validation/qualification activities including creating validation strategies and plans; defining requirements (URS) and supporting supplier acceptance (FAT/SAT) and execution of IQ/OQ/PQ; author/review protocols and reports in line with GMP and ISO 13485 expectations.

• Supporting and executing change controls.

• Participating in problem solving and providing hands-on technical support to operations by troubleshooting process deviations equipment failures and yield losses using structured root-cause analysis and supporting robust corrective actions.

• Support continuous improvement initiatives (Lean/Six Sigma) to improve process reliability capability and robustness.

• Participate in nonconformance investigations and CAPAs related to manufacturing processes and equipment; ensure actions are effective documented and closed on time.

• Support internal/external audits and maintain inspection readiness.

• Follow all company safety policies and other safety precautions within the work area.

• Follow J&J Records Management Policies for Convenience Information Records Retention Schedules Training.

• Follow GMP requirements.

• Work with the team to ensure all aspects of the business remain compliant and in an audit ready state.

• Responsible for communicating business-related issues or opportunities to the next management level

• Responsible for following all Company guidelines related to Health Safety and Environmental practices as 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

Qualifications/Experience

• Bachelors degree in Engineering (Mechanical Manufacturing Biomedical Chemical) or related technical discipline.

• Experience in a regulated manufacturing environment (Class III sterile medical devices preferred); working knowledge of ISO 13485 and ISO 14971; familiarity with FDA QSR/QMSR is a plus.

• Minimum 3 years of process engineering experience in manufacturing including hands-on troubleshooting and implementation in a production environment.

• Demonstrated experience with change control deviation/nonconformance investigations CAPA and engineering documentation (protocols reports work instructions) in an ISO/GMP environment.

• Knowledge of equipment specification and qualification (URS FAT/SAT IQ/OQ/PQ).

• Working knowledge of risk management and statistical/quality tools (e.g. PFMEA control plans DOE SPC capability analysis MSA/Gage R&R) to support robust process control.

• Fluency in English; Dutch is preferred.

• Cross-functional collaboration skills (Operations Quality Technical Operation R&D Supply Chain suppliers) with the ability to influence without authority.

• Demonstrated ability to work in accordance with procedures maintain high documentation quality and manage multiple priorities in a fast-paced regulated environment.

• Good communication stakeholder management and technical leadership skills with the ability to build trust at all levels.

This is what awaits YOU at J&J:

This is an opportunity to work within groundbreaking MedTech and to be a member of a Johnson & Johnson company with an excellent record in employee continuous professional development and business improvement.

We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.

Whether youre one of the 1000 people who work here or youre considering joining the team we offer:

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.
• Possibilities for further personal and professional development/education
• Excellent Benefits

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Required Skills:

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The anticipated base pay range for this position is:

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 locations 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.