Calibration Service Engineer- Laboratory

PCI Pharma Services•Rockford, IL

About The Position

The Calibration Service Engineer performs calibration testing, preventative maintenance, performance verification, troubleshooting, qualification, and repair of 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 monthly assignments and completes routine and non-routine tasks on time, independently resolves complex roadblocks, and coordinates calibration activities with other departments and external vendors. It maintains calibration documentation and records in compliance with GAMP, FDA requirements, cGMP, internal SOPs, and Good Documentation Practices. The engineer also maintains calibration standards and consumables, reports out-of-specification results, supports equipment onboarding, develops and updates procedures and work instructions, performs technical assessments, and trains personnel in calibration and preventative maintenance techniques. The position requires the ability to complete assigned and emergent tasks unsupervised, learn new technical disciplines, and apply prior experience to new work. Attendance is an essential function, and the role may require overtime and weekend work. PCI offers full-time employees paid time off, health insurance including dental and vision, a flexible spending account, and a 401(k) plan. The hiring rate is $77,600–$97,000, with eligibility for an annual performance bonus.

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 use 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 in mathematical or diagram form, and handling abstract and concrete variables.
Valid driver’s license.
Ability to use and calibrate tools and test equipment.
Working knowledge and understanding of laboratory and production instrumentation and equipment.
Ability to learn new technical disciplines and apply previous experience to new tasks.
Ability to complete emergent and assigned tasks unsupervised.

Nice To Haves

Experience with HPLC and GC.
Ability to effectively present information to different 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.
Ability to demonstrate original thinking and creativity.

Responsibilities

Calibrate and perform preventative and corrective maintenance on complex laboratory instrumentation and equipment.
Diagnose, qualify, troubleshoot, repair, and maintain laboratory instruments and equipment.
Manage monthly assignments and complete routine and non-routine maintenance and calibration tasks on time.
Resolve complex roadblocks independently.
Coordinate with external calibration vendors and communicate with other departments about scheduled calibration activities.
Collaborate with the manager and subject matter experts to solve complex problems.
Maintain organized, controlled documentation and records in compliance with GAMP, FDA requirements, cGMP, internal SOPs, and Good Documentation Practices.
Prepare and maintain data sheets, certificates, stickers, and other required paperwork.
Report out-of-specification results and adjust instruments where applicable.
Maintain inventory of calibration standards and consumable supplies that may affect calibration quality.
Enter data and use databases in accordance with internal SOPs and external regulatory requirements.
Support onboarding 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 assessments of routine equipment.
Train personnel in calibration and preventative 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/Supervisor.
Maintain attendance at work; the position may require overtime and/or weekend work.