Validation Expert in the Field of Active Pharmaceutical Ingredient Validation

Full-time, limited to 24 months. Shape a healthy future with us! More than 90 years of experience, pioneering spirit, and the trust of our over 600 employees make the Nordmark Group one of the world's leading manufacturers of biological and biotechnological active ingredients and pharmaceuticals – and at the same time a company with high innovative power: independent, medium-sized, owner-managed, firmly anchored at the site in Uetersen. So that your ideas become actions, we offer you room for active shaping and personal responsibility, an attractive salary package, flexible working hours, and diverse health measures – and thus the security to shape your own future healthily.

• Preparation, coordination, and, if necessary, execution of qualifications of equipment (e.g., bioreactor, chromatography, extraction systems), computerized systems, and rooms as well as validation of biological and biotechnological processes
• Creation of risk analyses, qualification/validation plans and reports, calibration plans, and review of calibration protocols
• Review and support of internal and external (supplier) qualification activities
• Coordination of the execution of process validations
• Statistical evaluation
• Coordination of cleaning monitoring of various equipment
• Deadline tracking
• Processing of change control and CAPA procedures
• Participation in preparation and execution of official GMP inspections and customer audits
• Creation of internal standards

• Completed degree with a natural science/technical focus (e.g., Biotechnology/Process Engineering)
• Professional experience in the described area of responsibility and in a GMP environment is an advantage
• Knowledge and experience in project management desirable
• Independent and results-oriented way of working
• Very good organizational and communication skills
• Solid MS Office user skills
• Basic knowledge of Statistical Process Control and OPEX (Six Sigma, Lean) an advantage
• Good English skills