Solution Preparation Engineer

1 week ago

Tuas, Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time $90,000 - $120,000 per year

Responsibilities

·       Accountable for solution (Buffers and Media) preparation for drug substance manufacturing according to GMP.

·       Accountable for cleaning and component sterilization of production equipment and facilities for drug substance manufacturing according to GMP.

·       Participate in the validation of solution preparation, cleaning and component sterilization of production equipment and facilities.

·       Participate and execute production projects and completing production plans on time.

·       Ensure accurate and timely documentation records in accordance with GMP requirements.

·       Assist in drafting/reviewing/revising SOPs, URS, PQ, MBR and other documents.

·       Participate in continuous improvement program

·       Lead deviations and change control management.

·       Participate and support all internal and external audits.

·       Good collaboration across functionally and perform other tasks as assigned by leadership.

Requirements

● Degree in Biological, Chemical, Pharmaceutical Engineering, or other related specialties; minimum 5 years' experience or candidates with equivalent work experience will also be considered.

● Ability to adapt to a GMP cleanroom environment, including the requirement to perform gowning and degowning.

● Possess good communication and comprehension ability.

● Display good working attitude, strong work ethic, and team collaboration.

● Able to perform shift work

● Be open to accepting temporary work assignments, including overtime, and other roles as required.

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