Biotechnologist, Solution Preparation

Responsibilities

• Operate and clean disposable and stainless-steel systems; prepare culture media and buffers in compliance with GMP requirements.
• Receive, review, and manage production materials in the workshop.
• Draft and update SOPs, MBRs, and related documentation.
• Participate in investigations, implement changes and deviations, and support audits and corrective actions.
• Coordinate and deliver training; maintain accurate and timely training records.
• Collaborate on GMP-related tasks within the department, including logbook and BPR reviews, cleaning, and sterilization of parts and consumables.
• Assist with daily administrative activities of the department.
• Perform additional responsibilities as assigned by the direct supervisor.

Requirement

• Diploma / Degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentation.
• 0 - 4 of relevant experience in drug substance bioprocess / pharmaceutical industry
• Familiarity with MES and PCS systems (e.g., DeltaV, Unicorn) is an advantage.
• Strong coordination and interpersonal skills; able to work cross-functionally and with multidisciplinary teams to achieve project goals.
• Good understanding of GMP standards and relevant regulations (e.g., 21 CFR Part 11, EU Annex 11).
• Team-oriented, proactive, and adaptable to dynamic timelines.
• Overseas Training Program is available