About Us
With an extensive offering of development services, state-of-the-art manufacturing equipment, and project support, we are truly a full-service CDMO biologics partner. Our approach pairs our expert knowledge base with an open mind towards scientific discovery so that together we can develop an optimal way to make our systems work for you and your biologics project, no matter how complex it may be.
Scope of Function:
The Senior Calibration Engineer is responsible for equipment management within master control and the planning, scheduling, and execution of calibration activities for the equipment and instruments in the calibration program. The role requires compliance with current regulatory / cGMP guidelines, standards, and policies.
Key Responsiblilites:
- Manage and maintain the current Equipment List, the Equipment Preventive Maintenance system, the Calibration Instrument List and Equipment Calibration systems within Master Control.
- At the beginning of each calendar year prepare a draft schedule for preventive maintenance activities for laboratory instruments, manufacturing equipment and reference instruments and share with Process Development, MSAT, Quality Control, Manufacturing & Quality Assurance.
- Coordinate preventive maintenance activities with manufacturing activities.
- At the beginning of each calendar year prepare a draft schedule for calibration activities for laboratory instruments, manufacturing equipment and reference instruments and share with Process Development, MSAT, Quality Control, Manufacturing & Quality Assurance.
- Coordinate instrument calibration activities with manufacturing activities.
- Update Process Development, MSAT, Quality Control, Manufacturing & Quality Assurance when changes occur to the annual preventive maintenance and calibration schedule.
- Assign and coordinate preventative maintenance activities for laboratory instruments, manufacturing equipment and reference instruments in accordance with the annual schedule.
- Undertake calibration activities for laboratory instruments, manufacturing equipment and reference instruments in accordance with the annual schedule.
- Maintain all calibration reference instruments, including ensuring appropriate protection and storage conditions of calibration reference instruments when not in use.
- Schedule, supervise and approve preventive maintenance activities for laboratory instruments, manufacturing equipment and reference instruments performed by outside vendors.
- Schedule, supervise, and approve calibration activities for laboratory instruments, manufacturing equipment and reference instruments performed by outside vendors.
- Where required, prepare laboratory instruments, manufacturing equipment and reference instruments for shipping to outside vendors.
- Operate, calibrate, and act as the primary SME on the REES environmental monitoring system.
- Assist in the preparation, implementation, and revision of preventative maintenance SOPs.
- Assist in the preparation, implementation, and revision of preventative maintenance FORMs.
- Prepare, implement, and revise calibration SOPs.
- Prepare, implement, and revise calibration FORMs.
- Assist with investigations associated with equipment preventive maintenance activities for laboratory instruments, manufacturing equipment and reference instruments.
- Assist with investigations associated with equipment calibration activities for laboratory instruments, manufacturing equipment and reference instruments.
- Serves as a resource to other technicians in the resolution of problems and issues.
- Maintain a clean and safe facility and equipment.
- Other duties as assigned.
The ideal candidate will have:
- Associates degree, bachelor’s degree, or appropriate experience
- Minimum 5 years of calibration experience.
- Experience working in a cGMP environment preferred.
- Proficient in Microsoft Office products.
- Must be willing to work overtime as needed.
Interacts with: All departments and outside contractors.
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