Maintenance Engineer
Maintenance Engineer - Cell and Gene Therapy CDMO
About Us
We are a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy. Our state-of-the-art facilities are at the forefront of advancing life-changing treatments for patients worldwide.
Job Overview
We are seeking a skilled and detail-oriented Maintenance Engineer to join our team. The successful candidate will be responsible for ensuring the optimal performance and reliability of our sophisticated manufacturing equipment and facilities.
Key Responsibilities
- Develop and implement preventive maintenance programs for complex bioprocessing equipment, warehouse and storage equipment
- Troubleshoot and repair mechanical, electrical, and instrumentation systems
- Ensure compliance with cGMP, safety, and regulatory requirements
- Collaborate with cross-functional teams to optimize equipment performance and minimize downtime
- Maintain accurate documentation of all maintenance activities and equipment history
- Participate in validation activities for new and modified equipment
- Manage spare parts inventory and vendor relationships
- Provide technical support during manufacturing operations as needed
- Contribute to continuous improvement initiatives and equipment upgrade projects
Qualifications
- Bachelor's degree in Engineering (Mechanical, Electrical, or Biomedical preferred)
- English Language
- Minimum of 2 years of experience in maintenance engineering, preferably in pharmaceutical or biotechnology industries
- Strong understanding of cGMP and regulatory requirements in cell and gene therapy manufacturing
- Proficiency in maintaining and troubleshooting complex bioprocessing equipment (e.g., bioreactors, filtration systems, chromatography systems)
- Familiarity with automation systems and control software used in bioprocessing
- Excellent problem-solving skills and ability to work under pressure
- Contact person for external service providers performing preventive maintenance
- Preparing Preventive actions needed for the asset
- Supervising internal staff and external contractors during the execution of maintenance and repair tasks
- Strong communication and teamwork skills
- Willingness to work flexible hours and participate in on-call rotations
Preferred Qualifications
- Experience with cell and gene therapy manufacturing processes
- Knowledge of clean room operations and maintenance
- Familiarity with computerized maintenance management systems (CMMS)
- Six Sigma or Lean Manufacturing certifications