2 years of experience with electronic and mechanical calibration, troubleshooting and repair experience
Working knowledge of calibration theories and principles
Computer literacy including Microsoft Office applications
Experience working within a GMP or regulated environment
Experience with asset management and/or ERP software
Preferred:
Application of technical skills in a Medical Device or Pharmaceutical GMP Facility
Some experience with audits; both auditing and responding to/participating in, GMP Audits
Skills & Competencies:
Working knowledge of temperature, pressure, and force calibration equipment and processes
Working knowledge of calibration theory to define test points, tolerances and procedures for new calibration items
Ability to collaborate with vendors, suppliers, and internal staff to schedule most appropriate. time for calibration of instruments
“Hands-on” mechanical and/or electrical aptitude
Good written and verbal communication skills
Ability to participate in root cause analysis
Ability to follow standard operating procedures and complete work in a compliant manner
Ability to adapt behaviors and activities during times of change and handle unexpected situations with little guidance
Ability to achieve productivity goals and targets to meet department goals with some guidance
Ability to follow defined procedures, proactively respond and problem solve
Ability to stay focused on tasks, apply learned skills/training on the job, understand job responsibilities, organize, compare, interpret data, analyze problems, and troubleshoot solutions with guidance
Work to acquire and develop new skills
Solid ability to collaborate and maintain cooperative work relationships with others
Consistently open and approachable to positively influence others
Engages co-workers with the Enable Values in mind
Solid ability to maintain a positive attitude, show empathy for others
Time management skills, the ability to use your time effectively or productively, at work
Physical Requirements:
Ability to remain sedentary for extended periods of time
Light work that includes moving objects up to 40 pounds
Position requires being physically present on the premises during regular company hours or as approved by management
RESPONSIBILITIES:
Perform or arrange for calibration of instruments in accordance with standard operating procedures
Maintain documentation and database pertaining to calibration activities
Assist with creating a database of instruments in SAP inclusive of technical information, calibration frequency and associated job plans
Complies with all PPE requirements and coaches and supports all employees’ adherence
Ensure calibration activities are scheduled and completed based on pre-determined intervals as well as ad hoc to support corrective maintenance activities
Schedule instrumentation calibrations with function managers to minimize downtime while ensuring calibrations are completed and documented in compliance with relevant SOPs and to GMP standards
Ensure that all contractors and vendors are properly escorted, trained and remain compliant while performing on-site calibration activities
Review and approve calibration certificates ensuring certificates are accurate, align with the job plans and calibration labels have been applied. Provide immediate notification to the area owner for out of tolerance findings.
Report out on key performance indicators
Support calibration documentation requests during customer and regulatory audits
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