Specialist (m/w/d) Qualification

Job Description

Simtra BioPharma Solutions, a leading contract development and manufacturing organization, is seeking a Specialist (m/w/d) Qualification to join their team in Halle/Westfalen, Germany. This role involves planning and executing timely maintenance, repairs, and qualifications of equipment and systems used in the production of sterile injectable drugs, including cancer therapeutics.

The Specialist will contribute to providing life-changing medications to patients worldwide.

Role Involves:

• Validating computer-based systems
• Selecting, commissioning, coordinating, and billing external service providers
• Controlling and monitoring internal and external costs for maintenance, repair, and qualification
• Creating and maintaining documents in German and English
• Implementing relevant Corporate Quality Procedures (CQPs)
• Supporting audits and inspections
• Conducting specialized training
• Continuously improving the overall qualification system and achieving savings

Requirements:

• Completed training as a chemical laboratory assistant (m/w/d) or a higher-level scientific-technical education
• Initial professional experience in the qualification of equipment for microbiological analysis is required
• Very good GMP knowledge is desirable
• Good analytical and technical understanding
• Organizational skills and ability to work in a team
• Fluent German and English skills are required

Simtra BioPharma Solutions Offers:

• Fair tariff-based remuneration including social benefits such as a 13th tariff salary, vacation pay, company pension scheme and additional long-term care insurance
• In-house modern canteen with attractive subsidies
• 30 days of vacation plus special leave
• Weekly working hours of 37.5 hours
• Job-Rad leasing
• Good transport connections and free employee parking with e-charging stations at favorable conditions
• Free company sports e.g. Badminton, soccer and fitness courses