Description

In this role, you will lead a team of CQV experts, ensuring that biotech manufacturing systems meet regulatory standards while fostering collaboration and continuous improvement across projects and operations.

Requirements

• •Bachelor, Master, Diploma in technical field or equivalent experience
• •Extensive experience in commissioning, qualification and validation (CQV) in biotech environment
• •Depth understanding of bioprocesses, GMP and biopharma production
• •Strong experience in CQV project management
• •Strong leadership skills and ability to communicate at higher levels
• •Strong business understanding in a CDMO environment
• •Fluency in English, German language skills advantageous

Tasks

• •Lead a team of senior CQV experts
• •Manage human resource functions including qualification and development
• •Mentor and hire team members
• •Make pay decisions and address team issues
• •Establish and manage a local group of CQV experts for biologics facilities
• •Support future operations users during periodic qualification
• •Collaborate on capital investment projects
• •Enhance operations teams with CQV expertise
• •Plan CQV activities to ensure resource availability for projects
• •Facilitate collaboration among key stakeholders
• •Secure operations input for CQ as a gatekeeper
• •Define and standardize the PQ approach
• •Build and manage a pool of external resources for CQV operations
• •Promote a culture of openness and teamwork

Benefits