Hybrid Technician II, Calibration (Cincinnati, OH, US, 45241) en Enable Injections

 QUALIFICATIONS

Required:

• Associates Degree / Technical certification
• 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