Qualification and Validation Expert – Sterile

We are seeking a highly skilled Qualification and Validation Expert with extensive experience in sterile line qualification and validation for a contracting role based in Frankfurt area, Germany. The ideal candidate will have a minimum of 4+ years of hands-on experience in sterile environments.

Responsibilities:

• Execute qualification and validation activities for sterile production lines in compliance with regulatory requirements and industry standards.
• Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and processes.
• Perform risk assessments and develop risk mitigation strategies related to qualification and validation activities.
• Coordinate with cross-functional teams including engineering, manufacturing, quality assurance, and regulatory affairs to ensure alignment and compliance throughout the qualification and validation process.
• Review and analyze validation data to ensure accuracy, completeness, and compliance with established protocols and regulatory requirements.
• Identify and implement process improvements to enhance efficiency and effectiveness of qualification and validation activities.
• Provide technical expertise and support to resolve issues and deviations encountered during qualification and validation activities.
• Maintain documentation and records

Qualifications:

• Degree in a relevant scientific or engineering field.
• Minimum of 4 years of experience in sterile line qualification and validation within the pharmaceutical or biotechnology industry.
• Fluent in German is mandatory.
• Strong understanding of regulatory requirements and guidelines related to sterile manufacturing processes (e.g., FDA, EMA, GMP).
• Experience with risk assessment methodologies and statistical analysis techniques.

Location: Frankfurt area, Germany (hybrid, 2-3 days on-site)
Duration: 1 year project (Starting date: As soon as possible)

Please apply directly online with your CV.

**Please only apply if you are eligible to work in EU**

headcount AG