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Operations Expert

3 weeks ago

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

Join a team of innovative engineers who revolutionize the pharmaceutical landscape by delivering patient-centric solutions.

Job Description

We are seeking an experienced Operations Engineer to support the startup and operational readiness of buffer/media and material preparation areas as part of a brownfield facility expansion project.

The role involves ensuring operational requirements are met through equipment onboarding, process readiness, and cross-functional coordination, ultimately supporting the transition to GMP manufacturing.

Main 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.
Required Skills and Qualifications

To succeed in this role, you will need:

  • 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.
Benefits

We offer:

  • Comprehensive Health & Wellness Coverage.
  • Generous Leave Policy including time off to care for aging family members.
  • Professional Development Opportunities.
Others

Maintain a safe working environment, adhering to EH&S and GMP regulations at all times. This is a fantastic opportunity to make a real difference in the pharmaceutical industry while advancing your career.