Senior Validation Engineer

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 of 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.

· 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

• 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

Location: Nijmegen, NL