Qualification & Validation Consultant - Sterile

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