About the Job

Die Wasserburger Arzneimittelwerk GmbH, part of the international Recipharm Group, manufactures sterile pharmaceuticals under contract in Wasserburg am Inn, which are administered via injection or infusion. To strengthen our team in the Qualification & Validation department, we are looking for a Validation/Qualification Engineer (m/f/d) for Sterile Production.

Your Responsibilities

• Planning, coordinating, and executing qualification, (re-)validation, and calibration activities in the manufacturing area (including cleanrooms and ventilation systems)
• Assisting in the preparation and execution of Aseptic Process Simulations (Media Fills)
• Creating, revising, and maintaining validation and qualification documentation (test plans, reports, SOPs)
• Assessing new regulatory requirements and evaluating their feasibility in existing processes
• Providing subject-matter support during authority and customer audits (national/international)
• Working in close cooperation with production, engineering, and quality assurance

Your Profile

• Completed degree in engineering (e.g., biotechnology, process engineering, pharmaceutical technology) or a comparable qualification
• Professional experience in sterile filling or pharmaceutical production
• Experience in the field of qualification/validation is an advantage
• Good knowledge of regulatory requirements (GMP environment)
• Structured, diligent way of working as well as technical understanding
• Good written and spoken English skills
• Willingness to work during company holiday periods (project-dependent)

About the Job

Die Wasserburger Arzneimittelwerk GmbH, part of the international Recipharm Group, manufactures sterile pharmaceuticals under contract in Wasserburg am Inn, which are administered via injection or infusion. To strengthen our team in the Qualification & Validation department, we are looking for a Validation/Qualification Engineer (m/f/d) for Sterile Production.

Your Responsibilities

• Planning, coordinating, and executing qualification, (re-)validation, and calibration activities in the manufacturing area (including cleanrooms and ventilation systems)
• Assisting in the preparation and execution of Aseptic Process Simulations (Media Fills)
• Creating, revising, and maintaining validation and qualification documentation (test plans, reports, SOPs)
• Assessing new regulatory requirements and evaluating their feasibility in existing processes
• Providing subject-matter support during authority and customer audits (national/international)
• Working in close cooperation with production, engineering, and quality assurance

Your Profile

• Completed degree in engineering (e.g., biotechnology, process engineering, pharmaceutical technology) or a comparable qualification
• Professional experience in sterile filling or pharmaceutical production
• Experience in the field of qualification/validation is an advantage
• Good knowledge of regulatory requirements (GMP environment)
• Structured, diligent way of working as well as technical understanding
• Good written and spoken English skills
• Willingness to work during company holiday periods (project-dependent)