Qualifications
Minimum of fifteen (15) years of experience in metrology, engineering &/or manufacturing, with specific experience in pharmaceutical manufacturing or other regulated industries
Knowledgeable in the following processes: Instrumentation, Controls (including Client/FMS & SCADA), Pharmaceutical Processes & Utilities, cLEAN® Process Improvement Methodologies, Systematic Problem Solving
Proven expertise in developing/planning/organizing/executing metrology systems & activities
Proven expertise in the creation of work plans for complex projects/plans being executed by cross functional teams
Physical & Other Requirements
Ability to lift up to 33 lbs
Ability to work in confined spaces & near operating equipment
Ability to work in loud noise environments
Ability to work hours necessary to support production & maintenance activities
Ability to work in an open office environment with the possibility of frequent distraction
Ability to adjust schedule to work with colleagues in other international time zones
Ability to travel internationally, as required Responsibilities
Support core processes by managing & optimizing metrologysystems, standards & calibration activities
Provide leadership & guidance to metrology personnel
Strive to continuously improve metrology processes
Coach & mentor director reports
Plan & coordinate calibration activities
Maintain & optimize QM structure, configuration & data within SAP
Maintain & optimize systems to manage instrument specifications
Maintain & optimize vendor calibration process
Support departmental & project portfolio projects
Ensure calibration activities are executed on time & to standard
Optimize time needed to perform calibrations to minimize impact on operations
Manage metrology standards for the site
Ensure cGMP’s are integrated into metrology systems
Ensure current industry & regulatory practices are incorporated in metrology processes & systems
Drive improvements to minimize deviations
Ensure deviations are completed on time & that counter measures eliminate the root cause
Ensure good communication & positive working relationships with key stakeholders
Drive improvements using cLEAN® methodology, including systematic problem solving