CSV Specialist

For our Engineering department (industrial automation) we are currently looking for a CSV Specialist. As a CSV Specialist you optimize and maintain the Computerized systems management and validation procedures and ensure optimal execution and continuous improvement of CSV processes per GMP (ISPE GAMP 5,21 CFR Part 11, Eudralex volume 4 Annex 11) standards. You lead or consult on CSV activities within IT/OT automation projects and changes to ensure adherence to GMP quality standards.

CSV Specialist

Key repsonsibilities:

Validation Strategy and Management:

Develop and maintain the validation strategy for computerized systems in line with GMP standards such as ISPE GAMP 5, 21 CFR Part 11, and Eudralex Volume 4 Annex 11. Ensure comprehensive management of validation activities to support regulatory compliance.

Execution of Validation Activities:

Execute validation processes, including planning, testing, and documenting validations for computerized systems to ensure they are fit for their intended use and comply with all relevant regulatory requirements.

Continuous Improvement of CSV Processes:

Continuously review and improve CSV processes and procedures to enhance their effectiveness and efficiency. Implement best practices to streamline validation activities and ensure ongoing compliance with GMP standards.

Leadership in CSV Activities:

Lead or consult on CSV activities within IT/OT automation projects and changes. Provide expert guidance to project teams, ensuring that all aspects of system validation meet quality and regulatory standards.

Cross-Functional Collaboration:

Collaborate with IT, Quality Assurance, Engineering, and other relevant departments to align validation activities with business and regulatory objectives. Facilitate communication and understanding across departments to ensure successful implementation of validation standards.

Documentation and Record Keeping:

Maintain meticulous records and documentation of validation activities, including validation plans, reports, and performance data. Ensure documentation is readily available and organized for audits and inspections.

Training and Mentoring:

Provide training and mentorship to team members and other staff on CSV principles, practices, and regulatory requirements. Develop training materials and conduct sessions to enhance the team’s competency in CSV.

Regulatory Awareness and Compliance:

Stay updated with changes in regulatory standards and guidelines affecting CSV. Implement necessary updates to validation processes to maintain compliance and address new regulatory challenges.

Risk Management:

Identify and mitigate risks associated with the validation of computerized systems. Employ risk management strategies during the validation lifecycle to prevent potential compliance issues.

Quality Assurance Collaboration:

Work closely with the Quality Assurance team to ensure that CSV practices adhere to quality standards and contribute to the overall quality goals of the organization.

Your profile

• A strong understanding of computer systems, software applications, and validation processes, as well as knowledge of relevant regulations such as GAMP5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.
• Experience in IT, automation or QC computerized systems.
• The ability to critically evaluate and interpret data, identify potential risks and non-compliance issues, and conduct gap analyses to ensure the effectiveness of the validation process.
• Strong knowledge of pharmaceutical manufacturing processes, quality systems, and regulatory requirements.
• Experience in developing and executing validation test plans, test scripts, and test cases.
• Excellent problem-solving, analytical, and risk-assessment skills.
• Experience within a GMP production environment.
• The ability to create and review validation documentation, ensuring accuracy, completeness, and compliance with regulatory requirements.

Our offer

• A fulltime employment of 40 hours per week
• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Contribution to travel expenses from the first kilometer
• Excellent accessibility by public transport and private parking available.
• Sound pension provision.