Calibration Service Engineer- Laboratory

Rockford, IL, USA

Full time

JR120105

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

** We are PCI.*
* Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

** 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 the following non-exhaustive list of laboratory equipment: UPLC, HPLC, GC, GC/MS, UV-Vis, Karl Fischer, FT-IR, Dissolution Tester, and IC.

*
* Essential Duties and Responsibilities:

** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

+ Calibrate and perform preventative and corrective maintenance of complex laboratory instrumentation that includes but is not limited to the following equipment: UPLC, HPLC, GC, GC/MS, UV-VIS, Karl Fisher, FT-IR, Dissolution Testers, Disintegration Testers, Stability Chambers, Autoclaves and Incubators.

+ Provides complex to specialized diagnosis, maintenance and preventative 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.

+ Ability to coordinate with external calibration vendors to service instruments and equipment

+ Ability to communicate professionally with other departments to coordinate calibration activities that are scheduled. Collaborates with manager and subject matter experts on problem solving and approaches to complex problems.

+ Maintain all documentation in an organized and controlled manner in compliance with GAMP and FDA.

+ Produce and maintain the proper paperwork (data sheets, certificates, stickers, etc.) in an organized and controlled manner in compliance with Good Manufacturing Practices, internal SOP's, and Good Documentation Practices.

+ Reporting OOS results when results fall out-with the expected ranges and performing instruments adjustments where applicable

+ Keep an inventory of the calibration standards and consumable supplies that can affect the quality of calibration results.

+ Data entry and database use in accordance with any internal SOPs and external regulatory requirement.

+ Advanced troubleshooting, analytical and problem solving skills.

+ Supports on-boarding of new equipment and instruments.

+ Experienced in utilizing and calibrating tools and test equipment

+ Working knowledge and understanding of laboratory and production instrumentation and equipment.

+ Ability to learn new technical disciplines and apply previous experiences to new tasks.

+ Perform periodic reviews and updates of calibration Work Instructions.

+ Be able to complete emergent and assigned tasks unsupervised.

+ Develop and manage calibration and preventative maintenance procedures and methods according to regulatory requirements and technical specifications for laboratory instrumentation.

+ Perform technical assessment of routine equipment.

+ Training of other personnel in calibration and preventative maintenance techniques.

+ Create electronic data sheets as needed.

+ Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

+ Performs other duties as assigned by Manager/Supervisor.

+ Attendance to work is an essential function of this position.

+ This position may require overtime and/or weekend work.

*
* Qualifications:

** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

*
* 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 has 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…