(Senior) Validation 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: (Senior) Validation Engineer - Fixed term

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 an (Senior) Validation Engineer located in Nijmegen.

Summary of Role:

Under the direction of Engineering manager, the (senior) validation engineer will:

• Manage site validation system according to company’s quality objective and quality plan.

• Organize validation activities deployment and ensure the closed-loop of the validation work.

• Lead validation continuous improvement.

Key Responsibilities:

Manage site validation system according to company’s quality objective and quality plan

• Manage overview of state of validation at site. Ensure that all process, material, equipment and facilities, etc., are properly qualified and validated.

• Maintain local procedures & templates for validation documentation and validation master plan according to the global quality directives / standard / guidance / cGMP and other local requirements together with other department.

• Maintain the validation master plan (VMP) and procedures, and ensure alignment with the company's quality management system.

• Establishing metrics and monitoring data for the qualification and validation activities, to identify trends and issues and to conduct periodic reviews and re-validation as necessary.

• Develop the strategy for continued process verification, and annual monitoring, ensure the plan in place. Ensures all critical process parameters and quality attributes are monitored or analyzed.

• Maintain all validation activities in an inspection ready status ahead of any internal or external audits.

• Establish and monitor key performance indicators (KPIs) and metrics for the qualification and validation, and report on the qualification and validation performance and effectiveness

Organize validation activities deployment and ensure the closed-loop of the validation work

• Ensure the proper documentation and review the qualification and validation deliverables, such as validation plan, risk assessments, traceability matrices, test scripts, deviations, and summary reports

• Oversee the execution of qualification and validation studies

• Draft and review the protocol and report for equipment, facility, utility, process validation / verification, cleaning validation, etc. and assist in its implementation

• Review the Test Method Validation (TMV) and Computer System Validation (CSV) protocol and report.

• Manage the validation deviation process and VD logbook.

Lead validation continuous improvement.

• Identifying and driving continuous improvement initiatives and projects to enhance the qualification and validation efficiency and effectiveness fostering a culture of continuous improvement

• Evaluating and recommending new technologies, tools, and methods to enhance qualification and validation processes and outcomes

• Follow up validation related NC and CAPA making sure they are completed on time.

Qualifications/Experience

• A relevant Bachelor’s/Master’s degree. Manufacturing or Engineering preferred; sciences would be considered.

• Have class III sterile medical device experience, familiar with ISO 13485 & ISO 14971. Medical Device or Pharmaceutical Industry experience is preferred.

• Good experience and understanding of ISPE C&Q and validation.

• Minimum of 5 years validation experience.

• Quality regulations and policy, projects Management

• Fluency in English/second language Dutch preferred

• Ability to work cooperatively with internal and external stakeholders

• Ability to perform duties in accordance with policies and procedures

• 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 – 25

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.