My growing client is an innovative biotech in the Netherlands – Amsterdam area, with several high-level projects ongoing. I’m collaborating with them exclusively to find a permanent solution for a Validation Manager.
Key result areas:
- Balance workload of and motivate direct reports and/or contract staff to accomplish department goals and objectives
- Manage protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
- Review and approve qualification documentation on behalf of the validation department
- Ensure performance of all qualification activities is in accordance with internal procedures, industry and regulatory guidance
- Initiate and own validation related change controls, deviations, and corrective and preventative actions
- Generate and maintain Validation program standard operating procedures
- Support the generation and maintenance of Validation program guidance documents (Validation Master Plans)
Qualifications
- Bachelor’s degree in Life Sciences or Engineering
- 5+ years of experience in qualification / validation of utilities, equipment, and processes in support of parenteral pharmaceutical or biopharmaceutical product manufacturing
- A minimum of 2 years supervisory or leadership experience (you will manage validation and instrumentation engineers)
- Knowledge of regulatory (EMA, FDA) requirements and industry guidance (ISPE, PDA)
- Core areas of validation expertise required;
Commissioning, Computerized System Validation, Environmental Qualification, Sterilization Validation, Shipping Validation, Requalification, Process Validation
Start Date: May/June (flexible)
Location: Noord Holland, Amsterdam
Contract: Permanent, 12-month to perm
Set-up: 40 hours, on-site
Package: Highly competitive benefit package
INTERESTED?
If you’re interested in the above description, please apply with your CV. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at m.vanos@panda-int.com