Temporary Assignment with Extension Option
Your Responsibilities
For an exciting opportunity within an international biopharmaceutical environment, we are seeking an experienced CQV Manager (Commissioning, Qualification & Validation). In this role, you will take both technical and operational responsibility for all CQV activities within a portfolio of CAPEX projects.
Key Responsibilities
- Develop and implement CQV strategies for new facilities, equipment, and processes
- Lead commissioning, qualification, and validation activities from planning through execution
- Ensure GMP and regulatory compliance throughout the entire project lifecycle
- Manage and coordinate CQV engineers, technicians, and external partners
- Take responsibility for resource planning, cost estimation, and schedule management
- Oversee installation, operational, and qualification activities (IQ/OQ)
- Collaborate closely with Engineering, Manufacturing, Quality, Validation, and Regulatory Affairs teams
- Identify, assess, and mitigate project-related risks
- Support the development of Project Execution Plans and Project Quality Plans
- Manage multiple projects and global stakeholders simultaneously
- Support audits, inspections, and compliance-related activities
- Drive continuous improvement of CQV processes, standards, and methodologies
- Coach and mentor team members, providing technical guidance and support
Your Profile
- Master's degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related discipline
- Minimum of 8 years of experience within the pharmaceutical, biotech, or life sciences industry
- Several years of experience as a CQV Lead, CQV Manager, or Project Manager
- Proven track record in large-scale CAPEX projects
- Strong knowledge of GMP and cGMP requirements
- Experience in the qualification and validation of manufacturing equipment and processes
- Fill & Finish experience is considered an advantage
- Excellent understanding of commissioning, qualification, and validation principles
- Experience in resource planning, budgeting, and project scheduling
- NEAT/Kneat experience is required
- DeltaV experience is advantageous
- Business fluent English skills
- German language skills are considered a plus
- Strong leadership and communication skills
- Experience working within international and matrix organizations
- Excellent stakeholder management and influencing abilities
- Analytical mindset with strong problem-solving capabilities
- High level of accountability and ability to drive results
- Proven ability to manage multiple complex projects simultaneously
- Strong business acumen and quality-focused mindset
What You Can Expect
- Involvement in strategically important investment projects
- International and innovative biopharmaceutical environment
- Collaboration with global teams and subject matter experts
- Challenging role with high visibility and responsibility