Key Responsibilities:
Support process-related projects including but not limited to Technology Transfer, Cleaning Validation (CV), Sterilization-in-Place (SIP) PQ, Process Qualification and Process Validation (PV) / Process Performance Qualification (PPQ). Draft Technology Transfer documentations such as facility fit assessment, control strategy, etc. Draft and review CQV and/or technology transfer deliverables including but not limited to risk assessment, technical justification / strategy / approach and qualification / validation protocols. Support CQV / PQ / PPQ activities. Support process comparability, resin lifecycle management, stability study and other process related activities. Requirements:
Hold Bachelor's degree in Life Sciences, Engineering or related field. Have worked for at least 5 years in pharmaceutical, medical device or related environment. Have either pharmaceutical manufacturing or MSAT experience. Have working competency in the area of Fermentation, Centrif...