Calibration Service Engineer- Laboratory

Summary of Objective

Performs calibration testing, preventative maintenance, performance verification, and troubleshooting on Analytical & Microbiological Laboratory equipment to assure proper working condition is maintained. This includes UPLC, HPLC, GC, GC/MS, UV-Vis, Karl Fischer, FT-IR, Dissolution Tester, and IC.

Essential Duties and Responsibilities

• Calibrate and perform preventative and corrective maintenance of complex laboratory instrumentation including UPLC, HPLC, GC, GC/MS, UV-VIS, Karl Fisher, FT-IR, Dissolution Testers, Disintegration Testers, Stability Chambers, Autoclaves and Incubators.
• Provide complex to specialized diagnosis, maintenance, qualification, troubleshooting and repairs of instrumentation/equipment.
• Manage monthly assignments to reliably complete routine and non-routine maintenance and calibration tasks on time; resolve complex roadblocks independently.
• Coordinate with external calibration vendors to service instruments and equipment.
• Communicate professionally with other departments to coordinate scheduled calibration activities; collaborate with manager and subject matter experts on complex problems.
• Maintain all documentation in an organized and controlled manner in compliance with GAMP and FDA.
• Produce and maintain proper paperwork (data sheets, certificates, stickers) in compliance with Good Manufacturing Practices, internal SOPs, and Good Documentation Practices.
• Report OOS results when results fall outside expected ranges and perform instrument adjustments where applicable.
• Keep an inventory of calibration standards and consumable supplies affecting calibration quality.
• Perform data entry and database use in accordance with internal SOPs and external regulatory requirements.
• Support on-boarding of new equipment and instruments.
• Perform periodic reviews and updates of calibration Work Instructions.
• Develop and manage calibration and preventative maintenance procedures and methods according to regulatory requirements and technical specifications.
• Perform technical assessment of routine equipment.
• Train other personnel in calibration and preventative maintenance techniques.
• Create electronic data sheets as needed.
• Adhere to all PCI, cGMP, and GCP policies, procedures, and rules.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.

Required

• Bachelor's Degree in a related field and/or 5-7 years related experience and/or training.
• College Level Mathematical Skills.
• Intermediate Computer Skills: ability to perform more complex computer tasks and knowledge of various computer programs.
• Full Professional Proficiency: ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• Valid Driver's License.

Preferred

• Ability to effectively present information to various people as the job requires.
• Ability to work independently and/or as part of a team.
• Excellent time management skills.
• Attention to detail.
• Willingness to make decisions.
• Ability to set and achieve challenging goals.
• Original thinking and creativity.
• Experience with HPLC and GC is preferred.