Calibration Engineer

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Mechanical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Nijmegen, Netherlands

Job Description:

Job Description:

Position: Calibration Engineer

Report to: Engineering Manager

Location: Nijmegen, Netherlands (Fully Onsite Role)

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

Job Description

GATT-technologies, a Johnson & Johnson Company is recruiting for a Calibration Engineer located in Nijmegen.

Summary of Role:

Under the direction of Engineering manager, the Calibration Engineer will:

· Be responsible for the calibration system ensuring calibration compliance of equipment as well maintains and improves status of equipment and components key to the manufacture and measurement of medical and other devices

· Performs the calibration duties, maintaining the department's calibration objectives with zero over dues and provides support to manufacturing, operations, and facilities.

· Support equipment maintenance, problem solving and continuous improvement

Key Responsibilities:

· Responsible for guaranteeing that all Inspection, Measuring, Test Equipment (IM&TE) measurements systems existing on site are calibrated, inspected, checked, maintained and safeguarded in a timely, compliant, efficient and consistent manner according to company calibration specifications, guidelines and procedures.

o Develop and maintain master schedule of calibration to ensure minimum impact on the continuity of daily operations.

o Ensure that all calibration work orders are arranged and executed in order of priority and recorded in a timely manner by internal personnel or external suppliers in accordance with current procedures.

o Judge and review the gages status based on the calibration result, maintain and label the different calibration status for all gages.

o Ensure non-conforming gages and overdue gages are segregated per requirements.

o Performs calibration procedures correctly by using the applicable calibration standards appropriately.

o Responsible for maintaining calibration records in Maximo system in a timely and compliant manner.

o Calibration and qualification of new equipment and input in calibration system.

· Responsible for maintaining calibration system

o Maintain local procedures & templates for calibration.

o Ensure all disposition and changes to calibration are made following procedures.

o Analyze the data from calibration activities, establish and verify the calibration intervals to ensure robust and reliable calibration system.

o Develop in-house calibration capability.

o Support and participate in projects/initiatives and develop new calibration methods.

o Manage spare parts inventory for calibration gages, ensuring that necessary components are readily available for repairs or external calibration.

o Ensure that the new measuring instruments meet the requirements when implemented in the calibration system.

o Support quality audits to ensure that calibration audits are always ready

· Support equipment maintenance

o Engages in developing and implementing equipment PMs to ensure uninterrupted production consistent with established standards standards.

· Support problem solving, includes problem definition, root cause analysis, efficiency or productivity improvement, and problem resolution.

o Identifies improvement options for the calibration systems.

o Assist with the implementation of improvements in calibration and engineering processes.

· Generates calibration related non-conformances (NC) according to local procedures. Support NCs & CAPAs related to calibration process.

· 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

· Bachelor’s degree in engineering preferred, Mechanical, Electrical, Electromechanical, Electronics, Metrology, Instrumentalist majors preferred and 4 to 6 years of experience in related fields preferred.

· Bilingual: Fluency in English, Strong written and oral communication in English required. Second language Dutch preferred

· Experience in the Medical Device and/or pharmaceutical industry or medical field. Knowledge of GMP/ ISO 13485 preferred.

· Experience in calibration system required. Knowledge of calibration and metrology required.

· Knowledge of electronic, pneumatic and electrical systems preferred.

· Knowledge of manufacturing principles and practices, and procedures preferred.

· Knowledge of information systems including but not limited to Enterprise Resource Planning (ERP), Maximo, Quality Systems & Documentation Control Systems is preferred.

· Capable to interpret the vendor maintenance/calibration/qualification reports to verify the effectiveness of the vendor’s work and adopt the outcomes into the process.

· Troubleshooting and problem solving.

· Knowledge of word processing, spreadsheet analysis, data management.

· Proper communication skills; making complex issues easy for others to understand when acting as a core team member in projects.

· Ability to work cooperatively with internal and external stakeholders

· Ability to build strong working partnerships, trust and credibility at all levels

· Organizational, collaboration, communication and leadership skills

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 you’re one of the 1000+ people who work here, or you’re 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

#LI-SP5

Job Function:

Supply Chain Engineering

Job Sub Function:

Mechanical Engineering

Job Category:

Scientific / Technology

Primary Job Posting Location:

Nijmegen, Netherlands

Additional Job Posting Locations:

Legal Entity Name:

8354-GATT Technologies B.V. Legal Entity

Pay Grade:

24

Employee Type:

1-year Fixed Term

The anticipated base pay range for this position is 44.700 EUR to 70.840 EUR on an annual basis and includes 8% holiday allowance.

Required Skills:

Preferred Skills:

Analytical Reasoning, Auto-CAD Design, Design Thinking, Execution Focus, Industrial Hygiene, Issue Escalation, Lean Supply Chain Management, Mechanical Engineering, Problem Solving, Product Reliability, Project Engineering, Project Management, Project Management Methodology (PMM), Quality Control (QC), Regulatory Compliance, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technical Credibility, Technologically Savvy

The anticipated base pay range for this position is 44.700 EUR to 70.840 EUR on an annual basis and includes 8% holiday allowance.