Metrology Specialist

PCI Pharma Services•Philadelphia, PA

3d•Onsite

About The Position

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. The Metrology Specialist is responsible for the oversight, calibration, and maintenance of measuring equipment site-wide and ensure compliance with GxPs as well as global/site requirements for calibration compliance under minimal supervision. The Metrology Specialist will improve and support the safe and effective completion of calibrations and support troubleshooting, problem solving, data analysis, and project implementation for measurement systems. There are no supervisory responsibilities for the role.

Requirements

Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
College Level Mathematical Skills
Advanced Computer Skills: Ability to perform the most complex computer tasks and operate 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.
High Standard of Report Writing
Ability to effectively present information to various people as the job requires.
Ability to follow instructions and respond to management direction.
Ability to identify and resolve problems in a timely manner.
Ability to work independently and/or as part of a team.
Knowledge and experience in cGMPs, FDA and other international regulatory agency regulations.

Nice To Haves

Knowledge of statistics, Six Sigma, DOE, and other improvement techniques.
Ability to support and lead cross-functional teams in Gauge Repeatability & Reproducibility.
Application of Failure Mode Effect Analysis.
Experience utilizing Minitab or similar programs for statistical analysis.

Responsibilities

Perform complex calibrations in the areas of temperature, pressure, conductivity, humidity, flow, mass, etc.
Accurately perform complex mathematical formulas relating to calibrations.
Ensure all calibrations are performed per regulatory, GxP, and global/site requirements.
Collect, compile, measure, record, and trend data gathered from calibrations.
Evaluate measuring equipment performance and effectiveness of tasks and frequencies.
Perform failure investigations (non-conformities) related to Metrology/Calibration processes.
Write/Improve calibration procedures and methods according to technical requirements.
Support and/or execute studies and testing involving measuring equipment.
Provide coaching and support to process owners for measuring equipment and instruments (calibration specifications, problem solving, instrument selection, failure investigation).
Drive improvements in calibration methods, standards, and specifications to meet customer/site needs.
Coordinate calibration contractors for performance of calibrations on and off site.
Maintain critical metrology standards, equipment, and tools.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Knowledge of NIST and ISO related standards.
Attendance to work is an essential function of this position.
Performs other duties as assigned by Manager/Supervisor.