Mission Description
Commissioning manager oversees the commissioning process for new facilities, equipment, or systems used e.g., HVAC. He/she will be the team leader to work with internal and external stakeholders, ensure safety, project schedules and progress tracking.
Key Responsibilities:
- Project Management: Coordinate and manage all commissioning activities for new pharmaceutical facilities, equipment, or system upgrades. Develop and execute commissioning plans, ensuring alignment with project objectives and timelines.
- Regulatory Compliance: Ensure that all commissioning activities comply with relevant regulatory standards GMP and other industry regulations.
- Collaboration and Coordination: Work closely with cross-functional teams including engineering, quality assurance, regulatory affairs, and production to ensure seamless commissioning processes. Collaborate with external contractors or vendors as necessary for commissioning activities.
- Documentation and Reporting: Oversee the documentation of commissioning activities, preparing comprehensive reports and documentation. Maintain accurate records of commissioning processes, test results, and validation documentation.
- Troubleshooting and Issue Resolution: Identify and resolve any issues or discrepancies encountered during the commissioning process. Implement corrective actions and ensure that systems or equipment function as intended.
- Resource and Budget Management: Manage resources, budgets, and timelines associated with commissioning projects, ensuring efficient utilization of resources
Qualifications and Skills:
- Bachelor's or Master's degree in a relevant field (e.g., Engineering, Pharmaceutical Sciences, etc.).
- 10-15 years experience with pharmaceutical manufacturing, commissioning, or validation roles.
- Strong understanding of regulatory requirements and compliance standards in the pharmaceutical industry.
- Excellent project management and organizational skills.
- Strong communication and interpersonal abilities to collaborate effectively with diverse teams.
- Attention to detail and ability to troubleshoot and solve problems effectively.
- Proficiency in documentation and report writing.
- Familiarity with relevant software and tools used in commissioning activities.
