Description
Responsibilities- Generate validation IOQ 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.
SKILLS
CRITICAL SKILLS/KNOWLEDGE:
Computer skills in Microsoft Office, including Excel and Outlook; 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. The following experience is preferred to have: experience in Validator 2000; previous validation experience on the site. Must have minimum of 3 years in GMP manufacturing validation engineering. Experience with IQ/OQ Engineering specification documents needed (4-7 years of experience). Biopharmaceutical and Manufacturing experience (4-7 years) also required.
Synectics is an Equal Opportunity Employer.