Senior Validation Engineer

Responsibilities: Lead and support all day-to-day qualification activities related to utility, facility and controlled temperature unit (CTU) / shipping validation for the Singapore facilities for Drug Product and Drug Substance, in accordance with approved Validation SOPs / Plan / Policies. Be responsible for validation status maintenance after release. Act as key focal point for quality system topics related to respective area of qualification for example deviations investigation, change management, CAPA identification etc. Support to analyze trends, identify and resolve issues that potentially impact validated status of the systems. Act as a Subject Matter Expert for Qualification and Validation (related to utility, facility and controlled temperature unit (CTU) / shipping validation) and front customer / regulatory audits. Develop and execute validation protocols and reports for initial and subsequent re-qualification, including supporting site discrepancies and deviations investig...