Project engineer Validation

The goal of the position is to bring and maintain the validation of systems, processes, installations, and equipment within the organization at the desired level. In doing so, legal frameworks and particularly pharmaceutical guidelines and regulations must be observed, and a strategy must be determined, partly in consultation with the quality managers of customers.

• Performing internal audits and guiding external audits (internal, customers, notified bodies) in the context of validation.
• (Having) setting up, implementing, and ensuring validation studies, in consultation with employees from Operations, Supply Chain, Technical Service, and QA.
• (Having) documenting all validation activities and validation results.
• Contributing to the improvement and optimization of personnel, processes, systems, and implemented procedures.
• Drafting procedures regarding validation activities.
• Assessing the required validation following (proposed) changes in systems, processes, installations, or equipment.
• Ensuring the validation of systems, processes, installations, and equipment is initiated and implemented in a timely manner.
• Ensuring the performed validation activities are of a good level and comply with the prevailing international laws and regulations in the field of validation and GMP.
• Ensuring implemented changes do not affect the validation status of systems, processes, installations, and equipment.
• Bachelor or Master of Industrial Sciences
• A few years of experience within a pharmaceutical production environment is a plus
• Familiar and acquainted with GMP guidelines, pharmaceutical guidelines, knowledge of microbiology, hygiene, etc.
• Experience with quality systems, procedures, training, etc.
• Can work with MS-office
• Good knowledge of English (written and spoken)
• Experience in writing reports
• Driven personality
• Ownership (sense of responsibility)
• Can organize tasks independently and set the right priorities, as well as work in a team.
• Purposeful
• Analytical and "open minded" thinking ability