Solution Preparation Engineer

2 weeks ago

Tuas West Region, Singapore WuXi XDC Full time $60,000 - $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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