Qualification & Validation Manager

The Qualification Manager is responsible for the CSV and qualification program at Basel DS Manufacturing, as well as activities to maintain qualified status in collaboration with the engineering and operators at Basel Drug Substance Manufacturing (for biochemical and chemical manufacturing processes).

Your Profile:

• Master's degree in chemical engineering, biotechnology, or a similar discipline and more than two years of experience in a pharmaceutical GMP environment.
• Familiarity with the qualification and validation of pharmaceutical production facilities and laboratory equipment.
• strong IT skills and excellent German and English language skills.

Tasks & Responsibilities:

• Management and coordination of CSV and qualification projects, approval of qualification plans and reports in eVal
• Creation of qualification strategies, risk analyses, qualification plans and reports
• Processing of changes, deviations, CAPAs, and creation of technical assessments for stakeholders
• Development and implementation of suggestions for improvements to the device qualification and system validation concepts
• Representation of qualification and validation topics during authority inspections as well as in local and global networks, task forces or project teams
• Collaboration with partners from site engineering, IT, manufacturing companies and compliance departments.
• Work in an environment with a strong team spirit, timely and effective communication, a sense of urgency and a high motivation to achieve the company's goals

Must Haves:

• Master's degree in chemical engineering, biotechnology, a similar discipline or chemical engineer
• At least 2 years of solid experience in the cGMP environment relevant to the pharmaceutical
• Experience in the operation, qualification and validation of pharmaceutical production plants and laboratory equipment
• Very good written and spoken German and English skills
• MS Office, Gsuite, Visio, eVal, Lucid Chart knowledge
• Good interaction with stakeholders
• Team spirit
• Sense of urgency

Nice to haves:

• Veeva and eVal experience

Sounds interesting? Apply now – we’re looking forward to receiving your applications!

Application Submission Deadline: 07.11.2025