Job Description

For one of our clients operating in a GMP-regulated biopharmaceutical manufacturing environment, we are seeking an experienced Senior Validation Engineer to support qualification, requalification, and validation activities on complex production systems.

Responsibilities

Prepare, review, and approve validation and engineering documentation (protocols, reports, procedures, rationales) Lead qualification, requalification, and revalidation activities for GMP systems and equipment Define requalification strategies in collaboration with Quality Assurance and system owners Ensure validation activities comply with current GMP and regulatory requirements Support regulatory inspections and customer audits Perform gap analysis and propose corrective or improvement actions Coordinate validation activities executed by external contractors Execute routine and non-routine validation work orders in compliance with GDP Contribute to continuous improvement initiatives Identify training needs and support training activities Participate in calibration and periodic review activities Promote a safe and quality-driven working environment

Profile

Bachelor's degree in Engineering, Biotechnology, Quality, or related field Minimum 10 years of experience in engineering or validation within a regulated industry (or Master's with relevant experience) Proven experience in qualification and validation in pharmaceutical or biopharma manufacturing Strong knowledge of cGMP and FDA/EU regulatory requirements Experience with electronic documentation and quality management systems Strong technical writing skills and attention to detail Experience in international and multicultural environments Proficient with standard IT tools (MS Office) * Fluent in English; German or another European language is a plus