Calibration Technician, Senior

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY
The Calibration Technician, Senior is responsible for maintaining and improving the cGMP Calibration Program at AGC Biologics facilities. This is a key position in the readiness of the instrumentation and equipment for new Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Perform calibration work on complex instruments such as Temperature, Pressure, Electronic, Flow, Weight, Level, Speed, pH & Conductivity, Laboratory Equipment and other manufacturing and utility system instrumentation.

• Perform troubleshooting, installations and repairs of complex instrumentation on production, laboratory and facility systems, ensuring all systems and devices are calibrated in accordance with manufacturer's specifications and AGC Biologics internal SOP's.

• Maintain a safe work environment; work in a safe manner following all safety SOP's and wear Personal Protective Equipment as required.

• Maintain assigned area of ownership within the facility to support inspection readiness and general facility upkeep for support of clinical and commercial manufacturing.

• Complete calibration work orders and engineering change controls within the allotted time.

• Maintain all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP's by the utilization of the site CMMS and Document Management Systems.

• Assist Equipment Owners determine the appropriate Calibration Information for their processes through the evaluation of Instrument specifications.

• Assist in Regulatory and Internal Audits / Inspections.

• Assist in qualification activities related to Instrumentation and Process improvement projects.

• Assist with Off-site Calibration Activities, communicating with Vendors to get calibration quotes, etc., and Interface with calibration contractors, ensuring work is compliant with AGC SOP's and cGMP's within the facility.

• Assist in the review and development of Calibration Department Procedures.

• Assist in the development of investigations and initiation of any documentation resulting from 'Out of Tolerance' conditions with respect to instrumentation.

• Provide training, coaching and technical direction to lower-level Calibration Technicians.

• Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.

LEADERSHIP SKILLS

• Demonstrated ability to works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations to management

• Demonstrated good interpersonal skills, customer focus, and professionalism.

• Applies understanding of how the team relates to other related areas to improve efficiency of own team

• Recognizes performance improvements and conveys feedback constructively

• Works across teams effectively

QUALIFICATIONS 
Required:

• Associate's degree in a related discipline with a minimum of 5 years in calibrations activities experience of which at least 3 years must be in a cGMP or other FDA regulated operations.

• Experience with Start-Up & Commissioning of cGMP Facility.

• Strong written, verbal and interpersonal communications skills.

• Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.

• Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).

• Knowledgeable of Electrical, Mechanical, Control/SCADA, PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Biotechnology, Pharmaceutical, Medical Device Utilities Process.

• In-depth knowledge of calibration and documentation requirements for cGMP manufacturing.

• Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics with assistance when needed.

Preferred:

• Computer literate in Blue Mountain or similar computer based maintenance program desirable.

COMPENSATION

$40.35 - $55.48/hour

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our