Job Title: Senior CSV Engineer

Location: Amsterdam, Netherlands

Department: Engineering

Reports To: Engineering Manager

Duration: 6 months (with possibility of extension based on project needs)

Role Overview:

We are looking for a highly skilled Senior CSV Engineer to join our team. This role will involve planning, documentation, and execution support for the validation of new computerized systems and modifications to existing ones in a regulated environment. The Senior CSV Engineer will also support automation engineers with the documentation and strategy of deviations and Corrective and Preventive Actions (CAPAs). A key aspect of this role is the ability to challenge and refine existing quality system framework documents related to CSV, ensuring compliance while reducing the cost of compliance.

Key Responsibilities:

• Provide planning, documentation, and execution support for the validation of computerized systems, including new system introductions and modifications in a regulated environment.
• Support automation engineers with the documentation of deviations and CAPAs, ensuring effective strategy and resolution.
• Review and challenge existing quality system framework documents related to CSV, making recommendations to maintain or improve compliance while optimizing cost-effectiveness.
• Collaborate with cross-functional teams to ensure systems are validated in accordance with relevant regulatory requirements (e.g., GxP, 21 CFR Part 11).
• Maintain calm and demonstrate critical thinking when facing challenges in a fast-paced and regulated environment.

Skills and Qualifications:

• Ability to think critically, strategically, and pragmatically to address complex validation issues.
• Proficiency in writing and refining CSV documentation using standard templates.
• Strong communication and problem-solving skills, particularly in navigating challenging or high-pressure environments.
• Knowledge of PLC, DCS, or SCADA coding is highly valued.
• Proven experience in CSV or related roles within the Pharmaceutical or Medical Device industries.
• Ability to understand and interpret regulatory standards and apply them effectively to ensure compliance.
• Dutch language proficiency is a nice-to-have but not required.

Experience:

• Strong background and proven experience in Computer System Validation (CSV), particularly in the Pharmaceutical or Medical Device industries.
• Previous experience with automation systems, including PLC, DCS, or SCADA coding, is highly valued.
• Demonstrated success in working within regulated environments and supporting compliance-driven initiatives.

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.

Asha Longman