Job 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
Education, Experience & Licensing Requirements
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
Supervision Received: General Supervision
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope. Travel: Not Applicable Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.
