CSV / Automation Expert

SEC Life Sciences; Regensburg; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading global life sciences organization seeks a CSV / Automation Specialist for a contract role focused on validation and compliance in a GMP environment. This role involves managing documentation, executing validation activities, and collaborating with cross-functional teams to align with regulatory standards. Ideal candidates will have substantial experience in GMP settings and strong communication skills in German and English.

Qualifikationen

• Degree in a natural science discipline preferred.
• 5+ years in GMP-regulated manufacturing focused on validation.
• Fluent in both German and English.

Aufgaben

• Lead the qualification and validation of process control systems.
• Oversee computer system validation and equipment qualification activities.
• Ensure compliance with GxP standards.

Kenntnisse

Communication

Documentation Management

Regulatory Compliance

Process Qualification

Data Integrity

Ausbildung

Degree in Natural Science

Certifications in CSV

Tools

Automation Systems

Jobbeschreibung

Contract Opportunity: CSV / Automation Specialist

An exciting contract opportunity has arisen with a global life sciences organization 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

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

Experience and qualifications for the CSV / Automation Specialist role

1. A degree in a natural science discipline is preferred, supported by relevant certifications in CSV and data integrity
2. Strong background (ideally 5+ years) in a GMP-regulated manufacturing environment, focused on validation and qualification
3. Demonstrable experience in executing CSV activities and reviewing validation documentation end-to-end
4. Solid understanding of relevant regulatory requirements (EU/FDA) and best practices in system and equipment qualification
5. Fluent in both German and English, with strong written and verbal communication skills
6. 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.