Operational Readiness Specialist

2 weeks ago


Singapore beBeevalidation Full time $90,000 - $120,000

We are seeking an experienced professional to join our team as a Solutions Architect.

As a key member of our organization, you will be responsible for ensuring the operational requirements of our buffer/media and material preparation areas are met through equipment onboarding, process readiness, and cross-functional coordination.

Key Responsibilities
  • Support startup activities for buffer/media and raw material preparation areas, including equipment verification, commissioning, and handover.
  • Lead protocol writing, execution, review, and coordination of validation activities.
  • Participate in process and layout design reviews, ensuring alignment with manufacturing operational needs.
  • Work collaboratively with Engineering, Manufacturing, Quality Assurance, and CQV teams to ensure readiness for GMP operations.
  • Assist in the development, review, and implementation of operational documentation, including SOPs, batch records, and work instructions.
  • Coordinate mock runs, operator training, and readiness assessments to support go-live milestones.
  • Provide support for material movement, staging, and flow strategies within cleanroom environments, ensuring compliance with GMP standards.
  • Facilitate issue resolution during equipment startup and process simulations, escalating as needed.
Requirements
  • Bachelor's Degree in Engineering, Life Sciences, or related discipline from a recognized institution.
  • 3-7 years of relevant experience in pharmaceutical, biopharmaceutical, or related manufacturing environments.
  • Experience with buffer/media preparation processes and raw material handling.
  • Well-versed in equipment, process, cleaning, and computer system validation (CSV).
  • Prior involvement in facility startup or brownfield/greenfield expansion projects is preferred.
  • Knowledge of GMP regulations and cleanroom operations is required.
  • Able to work collaboratively with cross-functional teams and external vendors.
What We Offer
  • Generous Leave Policy.
  • Comprehensive Health & Wellness Coverage.
  • Professional Development Opportunities.
  • Inclusive Culture.


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