Manufacturing Validation Expert
13 hours ago
You will play a pivotal role in ensuring the quality of Agilent's production of reagents for cancer diagnostics, thereby improving patients' quality of life.
This involves leading all aspects of validation activities at the Glostrup manufacturing site. Collaborating with cross-functional teams is essential to ensure equipment, cleaning, and production processes meet ISO and GMP requirements.
Key Responsibilities- Create detailed documentation for validation plans, protocols, and reports for automated equipment, facilities, and cleaning processes.
- Design and develop cleaning procedures for new products and manufacturing equipment, implementing effective cleaning strategies.
- Work collaboratively to ensure adherence to cleaning program documentation and site initiatives.
- Support daily operations, including troubleshooting, NCR, and CAPA-handling.
- Implement process improvements to reduce delivery times and eliminate bottlenecks.
You will interact with various teams within Agilent, including QA, regulatory affairs, R&D, Warehouse, Sourcing, and Logistics.
Qualifications- A Master's degree in engineering, biology, or a related field such as chemistry or biotechnology is required.
- PREFERRED KNOWLEDGE: Cleaning and cleaning validation expertise.
- Experience managing GMP and regulated production environments.
- Troubleshooting and optimizing finished production processes.
- Fluency in Danish and English is mandatory.
- LEAN competences are beneficial.
- Opportunity to work among highly qualified and committed colleagues in an international growing organization developing and producing diagnostic products.
- Exciting challenges and development opportunities with a high level of influence.
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