Instrument Engineer

4 weeks ago

Durham, United States Cambrex Full time

Overview:

This role will oversee and support scheduling, tracking, and performance of work for the Metrology, Facilities, Validation, and Analytical Laboratory groups. This role will support the development of a corporate metrology program. The position will facilitate the accurate and timely scheduling of scheduled and on-demand instrument/equipment work events, as well as on-boarding of new equipment, processing requests for change, and managing any deviations (OOTs).

Responsibilities:

Support the development of calibration and maintenance policies and procedures with a specific focus on analytical systems and instrumentation
Mentor and train junior members in relevant metrology and qualification activities
Coordinate and lead meetings and sub team meetings as necessary and manage information flow and decisions in projects. Ensure the key stakeholders are informed of the timing of activities and their responsibilities related to the process
Execute and enter calibration, maintenance and/or validation events into the calibration database in an accurate & timely manner (with strong attention to detail) - Maintain calibration database for real-time accuracy
Obtain service quotes and scheduling offsite/onsite vendor calibrations
Maintain Spare Parts inventory and communicate effectively on time for any new spare parts requirements
Provide support/guidance to business owners regarding on-boarding of new equipment into the calibration management system database
Generate required documentation for new and existing instruments
Review vendor calibration documentation and events
Enter deviations/Out of Tolerance into deviation management system
Effectively demonstrate an understanding of cGMPs & how they apply to job-specific responsibilities
Follow accurate oral and written procedures in performance of departmental tasks
Remain current in industry best practices and regulatory guidance and implement sound, risk-based process improvements
Support client and regulatory audits and serve as a metrology technical liaison
Help drive a safety focused culture through implementation of safe processes and equipment

Qualifications / Skills::


Demonstrate organizational, leadership, and interpersonal skills working in a cross-functional, regulated environment
Knowledgeable in the functional operation of analytical systems (UPLC, GC-MS, HPLC, etc.). Experience with similar systems like Empower and Maximo is desired
Proficiency in calibration and troubleshooting disciplines covering the areas of pressure, temperature, torque, mass, thermometry, humidity, analytical, and DC & low frequency.
Ability to execute PM / OQs for analytical systems
Ability to organize and prioritize work in order to meet established timeframes and schedules
Requires the ability to recognize problems and recommend solutions based on sound technical understanding of the process and equipment to prevent instrument failures and downtime
Must be able to effectively research information outside of current knowledge base
Requires the ability to recognize problems and recommend solutions based on sound technical understanding of the process and equipment

Knowledgeable in enterprise systems including Blue Mountain Regulatory Asset Management System, Rees Environmental Monitoring System, and Master Control Document Management System

Qualifications:

Associate degree or higher in Engineering, Life Sciences, other related technical field or equivalent military training (PMEL etc.) and 3+ years of applicable (Metrology, Instrumentation, Calibration) experience or the equivalent combination of education and experience

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