Generate validation I/OQ prototol/test plan for controls systems, perform IO/OQ/CIP, OQ/SIP, OQ for cell culture and purification system; generate and facilitate the resolutions to any deviations during the execution; generate and facilitate the review and approval of the validation summary reports.
Preferred to have:
- Minimum 3 years in GMP manufacturing validation engineering.
- Strong writing and speaking communication skills in English
- Experience with manufacturing control systems such as PLC, SCADA
- Experience in cleaning validation and steaming validation
- Experience in taking swab samples and rinse samples.
- Experience in IQ/OQ Engineering specification documents
- Biopharmaceutical experience
- Manufacturing experience
- Computer skills such as MS Office
- Experience in Validator 2000
- Previous validation experience on the site.
- 19 months ago - save job