Pharmaceutical Process Specialist

3 days ago

Singapore beBeeOperational Full time

At the forefront of pharmaceutical innovation, we seek a seasoned professional to spearhead our buffer/media and material preparation initiatives.

The successful candidate will be responsible for ensuring seamless operational readiness through equipment onboarding, process validation, and cross-functional coordination.

Job Overview

This pivotal role requires a dynamic individual with expertise in engineering consultancy, commissioning qualification validation (CQV), and quality assurance. The ideal candidate will possess exceptional written and verbal communication skills, enabling effective collaboration with cross-functional teams and external vendors.

Responsibilities include:

  • Supporting startup activities for buffer/media and raw material preparation areas, including equipment verification and handover.
  • Leading protocol writing, execution, review, and coordination of validation activities.
  • Participating in process and layout design reviews, ensuring alignment with manufacturing operational needs.
  • Collaborating with Engineering, Manufacturing, Quality Assurance, and CQV teams to ensure readiness for GMP operations.
  • Assisting in the development, review, and implementation of operational documentation, including SOPs, batch records, and work instructions.
  • Coordinating mock runs, operator training, and readiness assessments to support go-live milestones.
  • Providing support for material movement, staging, and flow strategies within cleanroom environments, ensuring compliance with GMP standards.
  • Facilitating issue resolution during equipment startup and process simulations, escalating as needed.
Requirements

Qualified candidates will possess:

  • A 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.
  • Expertise in buffer/media preparation processes and raw material handling.
  • Knowledge of equipment, process, cleaning, and computer system validation (CSV).
  • Prior involvement in facility startup or brownfield/greenfield expansion projects is preferred.
  • Experience working collaboratively with cross-functional teams and external vendors.
What We Offer

We are committed to providing a comprehensive benefits package, including:

  • Generous leave policy.
  • Comprehensive health and wellness coverage.
  • Professional development opportunities.

Join us in shaping the future of pharmaceutical solutions, and take your career to new heights

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