Senior Upstream Bioprocess Commissioning Specialist

6 days ago

Singapore beBeeBioprocess Full time $90,000 - $120,000
Job Opportunity: Upstream Bioprocess Commissioning Manager

About the Role

We are seeking a seasoned professional to spearhead commissioning activities, oversee project execution, and ensure compliance with Good Manufacturing Practice (GMP) and regulatory requirements for bioprocess equipment in upstream operations.

Key Responsibilities:

  • Oversee commissioning, qualification, and validation of upstream bioprocessing equipment and systems.
  • Lead project planning, execution, and delivery within agreed timelines, quality standards, and performance metrics.
  • Collaborate with cross-functional teams (Engineering, Manufacturing, Quality, EHS, and Validation).
  • Manage vendor relationships, Factory Acceptance Testing/Site Acceptance Testing (FAT/SAT), and coordinate with contractors and suppliers.
  • Ensure project documentation meets GDP, GxP, and 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 us about your relevant qualifications and experience.

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