CSV / Automation Expert

Contract Opportunity: CSV / Automation Specialist
An exciting contract opportunity has arisen with a global life sciences organisation renowned for delivering complex, regulated projects within highly compliant environments. The company is committed to improving patient outcomes through innovation, and this contract offers the chance to contribute to meaningful work at the intersection of quality, technology, and regulatory science.

Working on a high-impact project, the successful contractor will play a key role in supporting the qualification and validation of process control systems and equipment used in GMP-regulated manufacturing. This role is ideal for someone who thrives in a structured, cross-functional setting and is confident managing documentation and compliance in line with GxP standards.

Your role as CSV / Automation Specialist

• Lead and support commissioning, qualification, and validation of process units (PU) and process control systems within a GMP production environment
• Oversee the planning, execution, and documentation of computer system validation (CSV) and equipment qualification activities
• Advise on and contribute to key validation documents such as DQ, IQ, OQ, PQ, risk assessments, and master plans
• Collaborate closely with internal departments and project stakeholders to ensure seamless execution of validation strategies
• Ensure compliance with all relevant regulations, standards, and internal quality requirements across lifecycle stages
• Provide guidance in lifecycle management for systems, automation technologies, and software applications

Experience and qualifications for the CSV / Automation Specialist role

• A degree in a natural science discipline is preferred, supported by relevant certifications in CSV and data integrity
• Strong background (ideally 5+ years) in a GMP-regulated manufacturing environment, focused on validation and qualification
• Demonstrable experience in executing CSV activities and reviewing validation documentation end-to-end
• Solid understanding of relevant regulatory requirements (EU/FDA) and best practices in system and equipment qualification
• Fluent in both German and English, with strong written and verbal communication skills
• Prior experience working with automation systems and equipment from leading manufacturers is highly advantageous

For immediate consideration, please apply today. Alternatively, reach out to discuss other contract opportunities in the life sciences validation and quality space.