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Biopharmaceutical Technical Specialist
2 weeks ago
We are seeking a highly skilled Biopharmaceutical Technical Specialist to join our team. In this role, you will be responsible for performing Readiness, Release and Run aspects of Manufacturing Operations as assigned.
You will lead investigations for deviations, non-conformities, trends and/or abnormalities which occur on product floor. Perform root cause analysis utilizing standard methodologies e.g. 5 Whys, Ishikawa Diagrams, causal branching, event and causal factor charting, Failure Mode, Effect and Cause Analysis (FMECA).
Interact with customers in the form of face-to-face meetings and/or teleconferences to communicate investigation findings/outcomes to the customer.
Required Skills and Qualifications- 3+ years of experience in Engineering or Biopharmaceutical processing
- Familiarity with FDA & EMA GMP and regulatory requirements
- Ability to lead and effectively facilitate discussion/projects in cross-functional teams
- Strong communication skills with internal and external stakeholders
- Ability to lead projects under tight timelines
- Advanced knowledge in navigating through Controlled Document Management System (DMS) and Quality Management system (Trackwise)
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
Daily company bus from the MRT location near your home to and from the Tuas site
Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums
OthersDevelop/revise the MBRs in support of technology transfers/process campaigns with technical information/instructions that meet the user requirements as well as approval of MBR template/structures
Initiate and complete the change request prior to the start of a required process run
Support with creation/revision of risk assessments such as operational, safety and data integrity risk assessments
Support equipment, material or supplier qualification activities related to Manufacturing
Prepare and support the assessment/rating of manufacturing deviations at the Deviation Review Board (DRB)
Manage rejected materials through defective material inspections, review and assess vendor reports for operational improvements
Participate in Customer and Regulatory Audits to present relevant topics (eg. Deviation, Change Requests, CAPA, etc.)
Support with follow-up audit requests such as follow-up action from audits