Senior Upstream Bioprocess Engineer

7 days ago


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

About the Role

We are seeking an experienced Bioprocess Specialist to lead commissioning activities and oversee project execution in our pharmaceutical manufacturing team. This role will focus on bioprocess equipment for upstream operations, including bioreactors, fermenters, media preparation, and associated utilities.

Key Responsibilities

  • Lead and manage commissioning, qualification, and validation of upstream bioprocessing equipment and systems.
  • Oversee project planning, execution, and delivery within agreed timelines and quality standards.
  • Collaborate with cross-functional teams, including Engineering, Manufacturing, Quality, EHS, and Validation.
  • Manage vendor relationships, FAT/SAT execution, and coordinate with contractors and suppliers.
  • Ensure project documentation meets regulatory guidelines.
  • Provide technical expertise on upstream process equipment and utilities.
  • Identify risks, troubleshoot issues, and implement corrective and preventive actions.
  • Drive continuous improvement initiatives to optimize commissioning and project execution processes.

Requirements

  • Bachelor's or Master's degree in Engineering, Biotechnology, Bioprocess, or related discipline.
  • Minimum 5 years of experience in commissioning, project management, or engineering within the pharmaceutical/biotech industry.
  • Strong expertise in upstream bioprocess equipment (bioreactors, fermenters, CIP/SIP systems, utilities).
  • Demonstrated project management skills with experience in cross-functional coordination.
  • Knowledge of GMP, GEP, and regulatory compliance requirements.
  • Excellent communication, leadership, and problem-solving skills.

Tell Employers what Skills you have: Vendor Relationships, Regulatory Compliance, Management Skills, Budgets, Upstream, Bioprocess, Project Planning, Biotechnology, Project Management, Regulatory Requirements, Manufacturing, Commissioning, EHS



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