Technical Specialist

Technical Specialist

• Target Onboarding: September 2026
  
• Location: Singapore (Biopharmaceutical Manufacturing Operations)
  

Job Description

We are seeking a Technical Specialist to support our core biopharmaceutical manufacturing operations on a contract basis across three critical phases: Operational Readiness, Run, and Release. In this role, you will play a pivotal part in supporting seamless technology transfers, driving continuous operational reliability, and leading complex deviation investigations to ensure timely product release.

Key Responsibilities

1. Operational Readiness

• Support technology transfers and process campaigns by developing and revising Master Batch Records (MBRs), Change Requests (CRs), and operational documentation.
  
• Manage operational risk assessments, facilitate pre-campaign training sessions, and ensure all readiness tasks are fully executed prior to campaign startup.
  

2. Operational Run

• Support the evaluation of manufacturing deviations within the Deviation Review Board (DRB).
  
• Manage CAPAs, Change Control System Requests (CSCCs), rejected material processes, and associated campaign tasks.
  
• Participate actively in audits and quality reviews focused on manufacturing process and deviation topics.
  

3. Operational Release

• Lead technical deviation investigations and trend analyses to identify root causes using structured problem-solving methodologies.
  
• Conduct precise product impact assessments and design effective CAPAs to support the timely disposition and release of manufactured lots.
  

Requirements

• Experience & Knowledge: Strong understanding of biopharmaceutical/pharmaceutical manufacturing processes and hands-on operational knowledge of manufacturing equipment.
  
• Technical Competencies: Proven experience in technical writing, root cause analysis (RCA), and managing Quality Management System (QMS) elements (Deviations, CAPAs, Change Controls).
  
• Soft Skills: Excellent verbal communication and presentation skills.
  
• Adaptability: High degree of agility to manage shifting deliverables and dynamic operational priorities.