More Details
Validation and Qualification Engineer (f/m/d) (DE)
[14616]
Qualifizierung / Validierung, PQ, Aseptische Herstellung, CQV
Job title: Validation and Qualification Engineer (f/m/d) Industry: Pharma Skills: Qualification/Validation, GMP, CQV, PQ, Change Management, Deviation & CAPA Management Ideal starting date: as of now Possible salary: from EUR 45,000.00/year Location: Lower Austria, Austria An established company in Austria is seeking an experienced Validation and Qualification Engineer (f/m/d) to join its team. In this role, you will be responsible for planning, executing, and documenting validation and qualification activities to ensure compliance with regulatory requirements. Tasks: ·Lead Commissioning, Qualification, and Validation (CQV) activities for equipment, processes, and sterilization ·Develop CQV plans and reports ·Provide technical support to equipment/system owners ·Conduct risk assessments and support change management ·Oversee Change Management, Deviation, and CAPA processes ·Ensure compliance with GMP, company, and safety regulations Qualifications: ·Degree in (Bio)Chemistry, Biotechnology, Engineering, or related fields ·Experience in CQV and aseptic processing in a pharmaceutical setting ·Knowledge of cleanroom and sterilization validation processes ·Strong problem-solving and analytical skills ·Fluent in German and English ·Proficient in MS Office The basic salary consists of the collective agreement salary (at least EUR 45,000.00/year on a full-time basis) and any market-adjusted overpayment. The actual salary will be determined on the basis of qualifications, professional experience and individual skills.
Location: Lower Austria, Austria
- Lead Commissioning, Qualification, and Validation (CQV) activities for equipment, processes, and sterilization
- Develop CQV plans and reports
- Provide technical support to equipment/system owners
- Conduct risk assessments and support change management
- Oversee Change Management, Deviation, and CAPA processes
- Ensure compliance with GMP, company, and safety regulations
Qualifications:
- Degree in (Bio)Chemistry, Biotechnology, Engineering, or related fields
- Experience in CQV and aseptic processing in a pharmaceutical setting
- Knowledge of cleanroom and sterilization validation processes
- Strong problem-solving and analytical skills
- Fluent in German and English
- Proficient in MS Office
Lisa Heimisch