Calibration Technician II (Manufacturing)

To install, calibrate, inspect and repair all levels of instrumentation equipment throughout the facility. Provide process enhancements and continuous improvement as subject matter expert for Calibration.

Responsibilities

• Performs and documents new instrument installations utilizing blueprints, wiring diagrams and schematics.
• Executes scheduled Calibration Work Requests on GxP equipment effectively and in a timely manner.
• Accurately and using good documentation practices (GDP) completes required documentation. Maintains appropriate records and files to complete accurate instrumentation reports.
• Works with Manufacturing, QC and R&D to quickly resolve unscheduled calibrated equipment technical issues or out of tolerance events to minimize downtime on the production line.
• Exhibits a positive and customer focused attitude that promotes team work across the organization.
• Reads and follows Policies, SOPs and work instructions. Contributes to the development and continuous improvement of these documents.
• Orders materials needed for repairs, manages vendor selection for outside work based on quality and cost of services following company financial policies.
• Effectively manages multiple vendors to ensure on-time delivery of instruments, proper documentation of results is provided and on-site services are performed adequately per company guidelines.
• Collaborate with Engineering and/or other technical team members to determine root cause and corrective and preventative actions during investigation events associated to Calibration.
• Ability to multitask and assess priorities to meet company timelines.
• Maintains a clean and orderly work environment and contributes to the company's 6S program.
• Practices safe work habits and completes required safety and environmental hazard training.  Able to interpret MSDS sheets.
• Able to read and understand engineering drawings and wiring schematics.
• Maintains compliance to training requirements.
• Operates, installs and repairs digital voltmeters, oscilloscope, volt-ohm meters, wattmeter, transmission measurement test sets, RF spectrum analyzers and other specialized test equipment.
• Communicates effectively with personnel at all levels and effectively participates in a team environment.
• Ability to escalate unresolved issues per company guidelines to ensure resources are allocated and issues are communicated across cross-functional teams. Inform appropriate personnel of problems or concerns in a timely manner.
• Contributes to the department's overall goal for cost reduction ideas.
• Manages purchase requisitions, purchase orders, invoices and quotes associated to Calibration and provides support to finance on these documents.
• Ability to train peers on installation and calibration best practices and techniques.
• Initiates and completes Notice of Events due to Out of Tolerance results for GxP instruments. Including preliminary impact assessment, probable root cause and preliminary corrective action.
• Support Engineering projects and product development activities without impacting critical path

Qualifications

Competencies:

Education / Experience:

High school graduation and five years of instrumentation experience or an equivalent combination of training and experience are necessary. Experienced in all phases of calibration, preferably pharmaceutical. Excellent communication skills both written and verbal.  Knowledgeable in all cGMP and FDA calibration requirements, or ability to identify resources when necessary.             

 

Judgment / Decision Making:

Under general supervision, exercises some judgement in accordance with well defined policies, procedures and techniques. Moderately complex work performed within established practices and procedures requiring original thinking.

               

Work Environment:

Majority of time spent in office environment, sitting at desk and operating computer.  Some work performed with exposure to chemicals, electrical current, fumes, moving parts, and odors.

 

Physical Demands:         

Required to lift and carry up to 50 pounds.  Often required to stand for up to an hour at a time with stooping and bending.  Carelessness could result in minor injury.