Responsibilities
- Conduct research to identify, define, and estimate the necessary materials, parts, labor, tools, equipment, and external suppliers associated with maintenance tasks
- Update the Computerized Maintenance Management System (CMMS) with detailed job plans
- Support the equipment life cycle by overseeing the onboarding, relocation, and decommissioning of assets
- Ensure the availability of parts for both maintenance plans and unscheduled repairs, as well as during plant shutdowns
- Create part requisitions as necessary to support maintenance initiatives
- Develop, coordinate, and implement maintenance shutdown schedules
- Perform critical path analysis and resource leveling while updating and monitoring progress throughout shutdowns
- Identify any impacts, delays, or necessary accelerations on the critical path and communicate these updates during shutdown meetings
- Schedule and coordinate all maintenance activities
- Lead bi-weekly coordination meetings with stakeholders to prioritize both short- and long-term maintenance and repair tasks, including routine maintenance
- Ensure all records within the CMMS regarding parts and maintenance plans are complete and accurate, making updates as necessary
- Assist in root cause analysis and continuous improvement initiatives to enhance equipment reliability and efficiency
- Support audits and inspections by providing maintenance records and ensuring adherence to compliance requirements
Requirements
- An associate’s degree and prior work experience in a GMP manufacturing environment
- 5+ years of experience in a maintenance planning and scheduling environment within a regulated environment, preferably in cell therapy or biopharmaceuticals
- Documented understanding of cGMPs, ISO standards, and industry best practices
- Must be able to act independently in selecting appropriate methods, means, and techniques for maintenance planning and scheduling
- Proficient in MS Windows, MS Excel, and MS PowerPoint
- Strong interpersonal skills with the capability to effectively communicate technical information
- Extensive knowledge of planning, coordinating critical path schedules, and creating maintenance job plans within CMMS
- Self-motivated and passionate about advancing the field of cell therapy
- Self-awareness, integrity, authenticity, and a growth mindset|
- Familiarity with workflows and processes within Blue Mountain RAM CMMS
- Strong understanding of GMP, FDA, and other regulatory requirements in a pharmaceutical or biotech setting
- Ability to read and interpret engineering drawings, P&IDs, and equipment manuals
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What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit.
The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope.
Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale.
Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need.
The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
