Role Summary:

We are seeking a detail-oriented CSV (Computer System Validation) Engineer to support a cutting-edge cell therapy manufacturing project. This role will involve validating computerized systems and equipment, ensuring compliance with GMP regulations, and collaborating closely with an Automation Engineer to integrate and validate automation systems.

Key Responsibilities:

• Author and execute validation protocols (IQ, OQ, PQ) for computerized systems and manufacturing equipment.
• Develop and manage the Validation Master Plan (VMP) and system lifecycle documentation.
• Ensure compliance with 21 CFR Part 11, GAMP 5, and other regulatory standards.
• Work closely with the Automation Engineer to validate automation systems (e.g., SCADA, MES) and ensure seamless system integration.
• Conduct risk assessments, data integrity reviews, and periodic system revalidation.
• Act as the CSV SME during audits and inspections, maintaining audit-ready documentation.

Qualifications:

• Education: Bachelor’s or Master’s in Engineering, Computer Science, Life Sciences, or a related field.
• Experience: 5+ years in CSV, in GMP-regulated environments (biopharma or cell therapy).
• Skills:
  • Expertise in validating systems like MES, SCADA, LIMS, and process automation tools.
  • Knowledge of 21 CFR Part 11, GAMP 5, and data integrity principles.
  • Strong collaboration and documentation skills.

Preferred:

• Experience validating equipment and systems in cell therapy manufacturing.
• Familiarity with Quality Management Systems (QMS) and automation lifecycle tools.

Why Join Us?

• Contribute to innovative, life-saving therapies.
• Collaborate with a passionate team of experts in a dynamic environment.
• Competitive compensation and career growth opportunities.

How to Apply:
Submit your resume to Wesley.Cann@darwinrecruitment.com.

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

Wesley Cann