Biotechnologist

• Performs functions associated with GMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials.

• Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment.

• Determines and may assist in developing methods and procedures to control or modify the manufacturing process.
  

Commissioning & Qualification Engineer (CQV Engineer)

• Manage end-to-end equipment lifecycle processes, from design specifications to operational readiness

• Ensure pharmaceutical and biologics manufacturing facilities and utilities meet strict cGMP regulations.

• Protocol Execution: Generating and executing C&Q protocols (FAT/SAT, IQ, OQ, VMP) for process systems, utilities, and lab equipment.

• Compliance & Validation: Ensuring systems meet cGMP and regulatory authority requirements.

• Troubleshooting: Investigating deviations and executing root-cause analyses for malfunctioning manufacturing systems (Delta V).

• Contractor Management: Supervising and guiding external vendors, contractors, and junior engineering staff.

Requirements:

• Min. Degree in any relevant science field

• Possess prior working experience in biotechnologist roles or commissioning engineering, preferrably from a bio-pharma environment.

• Familiar with DeltaV operations

• Able to work 12 hours rotating shift (day / night)

• Contract role

Interested candidates please send in your updated resume in MS Word Format to:

[email protected]

Subject: CQV Engineer / Biotechnologist

EA Personnel: Kate Leau Wei Xuan (R1552331)

Company Registration No.: 99C4599