About the Role
We are seeking an experienced Bioprocess Commissioning and Project Manager to join our pharmaceutical manufacturing team. This role will primarily focus on bioprocess equipment for upstream operations (e.g., bioreactors, fermenters, media preparation, and associated utilities). The successful candidate will lead commissioning activities, oversee project execution, and ensure compliance with GMP and regulatory requirements.
Key Responsibilities
- Lead and manage commissioning, qualification, and validation of upstream bioprocessing equipment and systems.
- Oversee project planning, execution, and delivery within agreed timelines, budgets, and quality standards.
- Collaborate with cross-functional teams (Engineering, Manufacturing, Quality, EHS, and Validation).
- Manage vendor relationships, FAT/SAT execution, and coordinate with contractors and suppliers.
- Ensure project documentation is in line with 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.
We thank all applicants for their interest. Only shortlisted candidates will be contacted.
