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.
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.
· 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
· 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
· Proficiency in maintaining and troubleshooting complex bioprocessing equipment (e.g., bioreactors, filtration systems, chromatography systems)
· 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
· Strong understanding of cGMP and regulatory requirements in cell and gene therapy manufacturing
· Familiarity with automation systems and control software used in bioprocessing
· 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
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth in a dynamic and innovative environment.
To apply, please submit your resume and cover letter detailing your relevant experience and why you're excited to join our team in advancing cell and gene therapies.
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