Manufacturing Operations Expert
6 days ago
About Takeda Singapore
Takeda's biologics manufacturing facility in Singapore focuses on producing life-saving medicines for patients with rare blood disorders such as Hemophilia A and B.
We are committed to delivering better health and a brighter future to people around the world.
Job Description
The individual will work independently with regular reporting to the line manager, supporting and coordinating routine GMP manufacturing lifecycle and day-to-day operational activities associated with products and process equipment at our Singapore site.
This includes but is not limited to Suite 1 Manufacturing, Suite 2 Manufacturing, and Manufacturing Support areas. The individual will also provide lead key initiatives not limited to continuous improvement, validation, and CAPEX activities.
Key Responsibilities
- Support EHS and cGMP compliance of day-to-day and tactical manufacturing activities and ensure production activities are executed successfully.
- Work hand-in-hand with shift teams to ensure adherence to the production plan, resolve issues, as required.
- Be considered to have more than one area of manufacturing expertise, for example, Upstream processing/Downstream processing/Equipment Preparation/Buffer Preparation and/or knowledge in key systems like EBM/XFP/CIP/SIP knowledge.
- Act as subject matter expert during audits, explaining and walking through specific process operations or investigations, as applicable.
- Carry out deviations investigations in the GEMS system, including product impact assessments and implement CAPAs.
- Be a change control owner in the CCMS system, if applicable.
- Maintain recipe configuration management documentation, if applicable.
- Carry out material support activities including liaising with MLCM or vendors to address material issues, if applicable.
- Develop and implement CAPAs arising from audits.
- Inform management of events impacting production schedule.
- Propose and review document revisions.
- Carry out work in a safe manner, notifying management of safety issues and risks.
Requirements
- Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses 7 years of relevant experience in the biotechnology or pharmaceutical industry.
- Excellent self-motivated team player with hands-on attitude and excellent communication skills.
- Able to work on odd hours as required.
- Good understanding of cGMP manufacturing aspects and had hands-on manufacturing experience.
- Excellent at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs).
- Possess good communication and presentation skills.
- Ideally be Green belt trained/certified and possess good understand of LEAN and Six Sigma concepts.
- Possess critical thinking skills.
- Full awareness of current Good Manufacturing Practices (cGMP).
- Proficient documentation skills and computer skills including Microsoft Excel/Word/Powerpoint.
- Good time management and team coordination skills.
- Ability to work in a matrix environment.
- Understanding of requirements from support functions and their capabilities.
- Experience as a system user of business systems such as C3ME, XFP and Trackwise.
Estimated Salary: $120,000 - $180,000 per annum
Location: Woodlands, Singapore
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