MSD (Merck & Co., Inc.) is seeking a Qualification & Validation Specialist to join our global manufacturing network in Krems. In this role, you will be responsible for leading qualification and validation activities for manufacturing operations, ensuring they meet GMP and safety standards while supporting our mission to deliver innovative health solutions.
What You'll Do
- Lead assigned Qualification and Validation activities.
- Prepare qualification plans, protocols, reports, and procedures based on internal and external rules and standards.
- Plan and execute equipment and system qualifications as well as cleaning and process validation in cooperation with equipment/process owners, contractors, and suppliers.
- Perform cycle development, qualification, and re-qualification of sterilization processes (thermal, chemical, other physical methods).
- Participate in and moderate risk analysis of equipment, systems, and processes.
- Plan and execute Computerized Systems Validation (CSV) in corporation with IT and Process Automation.
- Support improvement projects and problem solving for qualification and validation activities.
- Support change, deviation, and CAPA management.
- Assist in training new employees in equipment qualification, risk assessments, and validation exercises.
- Be compliant with company safety guidelines and capable of recognizing unsafe situations and acting safely on the job.
What We're Looking For
- Bachelor, Master or Engineering degree in Biotechnology, Process Engineering, (bio)chemistry, (micro)biology, or similar disciplines.
- Must be able to track qualification/requalification activities and communicate adequately (verbally/writing) at all levels of the organization.
- Experience in a GMP production company.
- Experience in equipment qualification and process validation.
- Strong knowledge and hands-on experience of (bio) process technology; microbiology; aseptic processing; and equipment design.
- Experience in the use of continuous improvement tools and methodologies.
- Energetic and enthusiastic team player; innovative mindset; strategic, analytical, and problem solving skills.
- Very good knowledge of German and English (verbal and written).
Technical Stack
- GMP Compliance
- Good Manufacturing Practices (GMP)
- Process Engineering
- Process Technologies
- Equipment Maintenance
- Microbiology
- Analytical Problem Solving
Team & Environment
You will work in the Manufacturing Operations team within a global manufacturing network.
Benefits & Compensation
- Attractive salary
- Outstanding social benefits
- Exciting work environment with varied tasks in an international environment
- Minimum annual salary of EUR 47.532,24
Work Mode
This is a hybrid position based in Krems.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
