Senior Technician, Calibration

Enable Injections Inc.•Sharonville, OH

1d•Onsite

About The Position

QUALIFICATIONS Required: Associates Degree / Technical certification 8 years of experience with electronic and mechanical calibration, troubleshooting and repair experience Working knowledge of calibration theories and principles High degree of 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 Technical writing to write calibration procedures 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, failure mode effects analysis (FMEA) and asset performance metrics Ability to follow standard operating procedures and complete work in a compliant manner Ability to independently adapt behaviors to deal with non-routine components of the job Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities Strong ability to achieve productivity goals and targets to meet department goals with little to no guidance Ability to follow defined procedures, proactively respond and problem solve Influence at the department level Strong 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. Understand current state and dynamics impacting work Exceptional ability to collaborate and maintain cooperative work relationships Foster teamwork, collaboration, and positively influencing others Consistently open and approachable when resolving highly sensitive issues Engages co- workers with the Enable Values in mind Exceptional ability to maintain a positive attitude, show empathy for others Display emotional tendencies that help support a positive work culture Time management skills, the ability to use your time effectively or productively, at work Prioritize work to meet business needs

Requirements

Associates Degree / Technical certification
8 years of experience with electronic and mechanical calibration, troubleshooting and repair experience
Working knowledge of calibration theories and principles
High degree of computer literacy including Microsoft Office applications
Experience working within a GMP or regulated environment
Experience with asset management and/or ERP software
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
Technical writing to write calibration procedures
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, failure mode effects analysis (FMEA) and asset performance metrics
Ability to follow standard operating procedures and complete work in a compliant manner
Ability to independently adapt behaviors to deal with non-routine components of the job
Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities
Strong ability to achieve productivity goals and targets to meet department goals with little to no guidance
Ability to follow defined procedures, proactively respond and problem solve
Influence at the department level
Strong 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. Understand current state and dynamics impacting work
Exceptional ability to collaborate and maintain cooperative work relationships
Foster teamwork, collaboration, and positively influencing others
Consistently open and approachable when resolving highly sensitive issues
Engages co- workers with the Enable Values in mind
Exceptional ability to maintain a positive attitude, show empathy for others
Display emotional tendencies that help support a positive work culture
Time management skills, the ability to use your time effectively or productively, at work
Prioritize work to meet business needs
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

Nice To Haves

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

Responsibilities

Train and mentor less experienced calibration technicians
Perform or arrange for calibration of instruments in accordance with standard operating procedures
Maintain documentation and database pertaining to calibration activities
Provide assistance in the troubleshooting and repairs or equipment and instruments
Write standard test method procedures relative to metrology 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
Through collaboration with functional area owners, schedule instrumentation calibrations with the objective of minimizing 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
Coordinate and maintain outside testing laboratories as Approved Vendors
Maintain calibration program to the latest cGMP and ISO guidelines as well as internal procedures
Support calibration documentation requests during customer and regulatory audits
Assist in preparation of yearly budget and reforecast as requested by Finance
Assist with creating database of equipment maintenance including maintenance intervals
Routinely publish list of required preventive maintenance coming due and provide to functional areas for execution
Track monthly progress of required maintenance activities and follow up with FAMs to ensure activities are completed on time
Review maintenance records for completeness and compliance with relevant SOPs and to GMP standards
Report out on key performance indicators
Support maintenance documentation requests during customer and regulatory audits