CSV Specialist

Are you ready to take on a unique and exciting opportunity as a Computer System Validation (CSV) Specialist in the Medical Device Sector? Johnson & Johnson is seeking a highly motivated individual to join our team in Nijmegen, Netherlands. This is your chance to be part of a world-class organization that is committed to innovation and delivering flawless quality in everything we do.

The Computer System Validation (CSV) Specialist is responsible for assessing systems at the Nijmegen site to ensure compliance with all relevant procedures and regulatory requirements. This role oversees the CSV program for the site.

The CSV Specialist provides technical leadership for validation activities, including developing validation documentation, offering expert guidance, and performing thorough reviews of all related documents. This position reports to the direction of Quality Engineering Lead.

Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Develop, and review lifecycle documents, including validation plans, system requirements, design specifications, protocols, and reports for GxP-relevant computerized systems.
• Develop and execute validation protocols. Create and implement testing procedures for computer systems following a risk-based approach to ensure they function as intended and meet regulatory requirements.
• Maintain validation documentation and ensure traceability throughout the system lifecycle.
• Work in collaborative manner with cross-functional teams to gather knowledge of the systems, collect data, discuss applicable system procedures.
• Conduct risk assessments and gap analysis. Identify potential compliance issues and areas of non- compliance within systems and processes.
• Ensure compliance with applicable regulations (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5) Nijmegen site CSV and data integrity procedures
• Act as SME for CSV during regulatory inspections and audits.
• Responsible for communicating business-related issues or opportunities to 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
• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support through software validation throughout the Software Validation Life Cycle.
• Provide Training/Consultation on CSV activities.

Requirements:

• Bachelor's degree or higher in Engineering, Computer Science, Life Sciences or related field.
• Minimum of 3-4 years of experience in software validation and/or quality assurance within a regulated industry (pharmaceutical, biotech, medical devices).
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and other relevant guidelines.
• Strong technical writing and documentation skills.
• Ability to work with cross-functional teams and to communicate effectively within diverse interdepartmental groups is required.
• Ability to work on own initiative and as a team player.
• Ability to prioritize multiple commitments and technical problem-solving duties.

Required Skills:

Computer System Validation (CSV)

Preferred Skills:

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

Location: Nijmegen, NL