Senior Upstream Bioprocess Engineer and Project Coordinator

5 hours ago

Singapore beBeeRegulatory Full time $100,000 - $150,000
Bioprocess Commissioning and Project Manager Role

We are seeking an experienced professional to lead commissioning activities, oversee project execution, and ensure compliance with GMP and regulatory requirements in the pharmaceutical manufacturing team. The successful candidate will focus on bioprocess equipment for upstream operations.

The key responsibilities include:

  • Leading and managing commissioning, qualification, and validation of upstream bioprocessing equipment and systems.
  • Overseeing project planning, execution, and delivery within agreed timelines and quality standards.
  • Collaborating with cross-functional teams including Engineering, Manufacturing, Quality, EHS, and Validation.
  • Managing vendor relationships and coordinating with contractors and suppliers.
  • Ensuring project documentation is in line with GDP, GxP, and regulatory guidelines.
  • Providing technical expertise on upstream process equipment and utilities.
  • Identifying risks, troubleshooting issues, and implementing corrective and preventive actions.

The ideal candidate will have:

  • A 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.

Vendor Relationships
GxP
Management Skills
Budgets
Regulatory Compliance
GMP
Upstream
Bioprocess
Project Planning
Biotechnology
Project Management
Regulatory Requirements
Manufacturing
Commissioning
EHS

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