Calibration Service Engineer- Laboratory

PCI Pharma Services•Rockford, IL

8d•$77,600 - $97,000

About The Position

The Calibration Service Engineer performs calibration testing, preventive maintenance, performance verification, troubleshooting, qualification, and repairs for analytical and microbiological laboratory equipment to ensure it remains in proper working condition. Equipment includes UPLC, HPLC, GC, GC/MS, UV-Vis, Karl Fischer, FT-IR, dissolution and disintegration testers, stability chambers, autoclaves, and incubators. The role manages routine and non-routine maintenance and calibration assignments, coordinates with external vendors and internal departments, maintains controlled documentation in accordance with GAMP, FDA requirements, GMP, internal SOPs, and Good Documentation Practices, and reports out-of-specification results. The engineer also maintains calibration standards and consumables, supports equipment onboarding, updates work instructions and procedures, trains personnel, and completes assigned or emergent work independently. Overtime and/or weekend work may be required.

Requirements

Bachelor's degree in a related field and/or 5–7 years of related experience and/or training.
College-level mathematical skills.
Intermediate computer skills, including the ability to perform more complex computer tasks and knowledge of various computer programs.
Full professional proficiency in speaking, reading, and writing for professional needs.
Very high reasoning ability, including defining problems, collecting data, establishing facts, drawing valid conclusions, interpreting technical instructions, and handling abstract and concrete variables.
Valid driver's license.
Working knowledge and understanding of laboratory and production instrumentation and equipment.
Ability to learn new technical disciplines and apply previous experience to new tasks.
Advanced troubleshooting, analytical, and problem-solving skills.
Ability to complete emergent and assigned tasks unsupervised.

Nice To Haves

Ability to effectively present information to various people as required by the job.
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.

Responsibilities

Calibrate laboratory instrumentation and perform preventive and corrective maintenance.
Diagnose, qualify, troubleshoot, and repair laboratory instruments and equipment.
Manage monthly assignments and complete routine and non-routine maintenance and calibration tasks on time, resolving complex roadblocks independently.
Coordinate instrument and equipment servicing with external calibration vendors.
Communicate with other departments to coordinate scheduled calibration activities and collaborate with managers and subject matter experts on complex problems.
Maintain organized, controlled documentation in compliance with GAMP and FDA requirements.
Prepare and maintain data sheets, certificates, stickers, and other records in accordance with GMP, internal SOPs, and Good Documentation Practices.
Report out-of-specification results and adjust instruments where applicable.
Maintain inventory of calibration standards and consumable supplies that can affect calibration quality.
Perform data entry and use databases in accordance with internal SOPs and external regulatory requirements.
Support onboarding of new equipment and instruments.
Use and calibrate tools and test equipment.
Perform periodic reviews and updates of calibration work instructions.
Develop and manage calibration and preventive maintenance procedures and methods according to regulatory requirements and technical specifications.
Perform technical assessments of routine equipment.
Train other personnel in calibration and preventive maintenance techniques.
Create electronic data sheets as needed.
Adhere to PCI, cGMP, and GCP policies, procedures, and rules.
Perform other duties assigned by the Manager or Supervisor.
Maintain attendance at work as an essential function of the position.