Oberbayern: Validation Expert (m/w/d) - Pharma

Our client, a manufacturer of innovative transdermal drug delivery systems, is looking for a:

Validation Expert (m/w/d)

• Planning, execution, and documentation of qualification activities (IQ, OQ, PQ) for rooms, equipment, processes, and media
• Organization and implementation of re-qualifications in accordance with current regulations
• Creation and maintenance of GMP-relevant documents, including URS, qualification plans, reports, and SOPs
• Ensuring compliance with legal requirements and internal company standards
• Coordination of internal and external processes, including qualifications, calibrations, supplier qualifications, as well as handling deviations and CAPA measures
• Continuous improvement and optimization of qualification processes

• Completed studies in pharmaceutical engineering, process engineering, engineering sciences, or a comparable field
• Several years of experience in GMP qualification/validation
• Sound knowledge of current GMP regulations, especially Annex 15, as well as relevant ISO and DIN standards
• Experience in planning and implementing qualification and validation projects, change management, as well as project management and coordination
• Very good German and good English skills
• Strong team spirit, excellent communication skills, and analytical thinking
• Independent and structured working style with strong conceptual skills
• Proficiency in Microsoft Office and SAP

• Attractive salary
• Travel cost allowance
• Subsidy for capital-forming benefits and retirement provision
• In-house cafeteria
• EGYM Wellpass
• Internal and external training opportunities
• Business bike leasing
• Free access to the Babbel language learning platform
• Corporate health management
• An open and positive work environment

Contact:

Mariana Chaumont
Senior Consultant
+49-(0)89-809130720