Senior Calibration Specialist
1 day ago
We are seeking a highly skilled Senior Calibration Technician to join our team at Divihn. As a key member of our laboratory operations team, you will be responsible for independently managing laboratory equipment calibrations, maintenance, and repairs in coordination with external vendors and laboratory staff.
Key Responsibilities:- Plan, schedule, and perform maintenance, calibration, and repairs on active equipment using the Computerized Maintenance Management System (CMMS).
- Oversee and manage onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment.
- Review and approve equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices.
- Initiate, write, and assist with investigations related to instrument calibration failures or other instrument-related issues.
- Induce new equipment, including developing calibration requirements and schedules in coordination with equipment owners.
- Research operating specifications of new equipment, obtain suitable standards, and establish calibration acceptance criteria.
- Conduct thermal mapping studies for controlled environments to validate and optimize equipment performance.
- Maintain and/or generate SOPs or other controlled documents pertaining to operation, maintenance, and calibration of laboratory instrumentation and equipment.
- Review system documentation, including user requirement documents and specification documents for instrumentation.
- Interface with multi-disciplinary teams regarding laboratory equipment, including lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT.
- Contact and obtain technical information from vendors or service providers.
- Thoroughly document all activities and review all data to ensure completeness and accuracy within the CMMS.
- Adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.
- Ensure all calibration and thermal mapping activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP).
- High School Diploma and 9+ years of metrology experience OR Bachelor's Degree and 5+ years of metrology experience is required.
- Experience working in the Pharma/Biotech industry.
- Understanding of calibration methodology and tolerances.
- Experience working with loop calibrations.
- Understanding of FDA and GxP regulations and requirements.
- Experience working in GMP, GLP environments.
- Experience investigating and completing CAPAs and deviations.
- Ability to read and interpret instrument technical drawings.
- Working knowledge and understanding of laboratory analytical instrumentation and small-scale manufacturing equipment.
- Ability to work independently in a fast-paced, highly interactive environment with excellent self-organization skills.
- Excellent verbal and written communication skills.
- Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.
- Bachelor's Degree in a relevant field.
- Certified Calibration Technician.
- Experience working in CLIA, and R&D laboratory environments.
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