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 conclusions. Be able to 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 part of a team.
- Ability to display excellent time management skills.
- Ability to demonstrate attention to detail.
- Ability to display a willingness to make decisions.
- Ability to set and achieve challenging goals.
- Ability to display original thinking and creativity.
- Experience with HPLC and GC is preferred.
The hiring rate for this position is $77,600-$97,000 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
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