Validation Engineer
90000 - 150000 USD per year
Company:Syner-G
Location:Greater Boston, San Diego, CA, Boulder, CO, India
Languages:English
Seniority level:Middle, 4-7 years
Experience:4-7 years
Skills:
AgileQAQA AutomationAPI testingManual testingDocumentationAttention to detailComplianceQuality AssuranceProblem-solving skillsTroubleshootingRisk ManagementProcess improvement
Requirements:
Bachelor’s degree in a related life science field. 4-7 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis. Validation expertise in Equipment, CSV, Method, and Process. Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Report writing experience for IQ, OQ, PQ, and CSV. Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people.
Responsibilities:
Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification. Support validation activities for Basecamp and client Tech Transfer projects. Write, review, and revise qualification/verification related documents. Write reports to summarize validation/verification/commissioning activities. Write procedures, investigations, protocols, reports, and change controls. Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes. Support the resolution of regulatory observations or manufacturing site issues. Execute periodic reviews and requalification for temperature chambers.
