Senior Metrologist – FCX/PCI – Raleigh, NC

Overview

The Senior Metrologist reports directly to the Team Leader, Manager, or Director depending on the organizational structure.  This position is on-exempt.  Twenty five to Fifty percent travel may be required based on project and client needs.

 

Expectations:

 

Metrologist I complete calibrations, qualifications, and preventive maintenance (PM) actions with accurate and timely GxP documentation, following PCI and/or client specific policies and procedures. They are expected to take a proactive role in supporting the Team and in providing client support and are expected to build a high level of trust with internal and client personnel. This trust is developed through consistently upholding PCI Values and demonstrating Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment.

 

In addition to the above expectations, the Metrologist II is expected to identify and execute tasks that enhance the ability of PCI to provide an ‘added value’ service for clients and provide guidance and direction on technical issues. The Metrologist II has a higher level of technical experience and expertise to troubleshoot issues, as well as assist in providing innovative, creative, effective, and long-term solutions. 

 

In addition to the above expectations, the SR Metrologist is expected to have a high level of technical expertise and the ability to provide strategic direction to Metrologists I and II. The SR Metrologist stays abreast of changing technology, industry best practices and international standards compliance requirements for accreditation through active participation in professional organizations such as the American Society for Quality (ASQ). The SR Metrologist works closely with clients to evaluate program needs, make improvement recommendations and initiate value-added solutions and services.

 

Responsibilities/Assignments:

Senior Metrologist 

  • Oversees and supervises calibrations, qualifications, and PMs with accurate and timely GxP documentation ensuring all Team members follow PCI or client specific policies and procedures in a safe manner
  • Provides guidance, direction and effective solutions to clients and PCI technical resources
  • Upholds, mentors and is a role model to other PCI associates; embraces the PCI philosophy and values of honesty, integrity, pride, accountability, teamwork and commitment
  • Proactively takes steps to ensure PCI and client owned equipment is handled and maintained properly, as well as trains other associates on proper use and handling
  • Develops client quotes and proposals
  • Proactively assesses project safety concerns and ensures PCI team members are in compliance with all client and PCI safety requirements
  • Develops test methodology for new test equipment to include templates, test points, safety consideration and special client requirements
  • Takes client relations initiative and proactively seeks to expand PCI services
  • May serve as “Project Lead” for select clients based on strong client ties and business needs

 

Skills Required:

 

Metrologist I

    • Basic understanding of Traceability, Substitution of Standards and Test Accuracy and Uncertainty Ratios as part of ISO 17025 requirements
    • Skilled with pneumatic, mechanical and electrical instrumentation, as well as manual and computer-based process control loops and systems
    • Understands and applies basic concepts of calibration and requirements including accuracy testing
    • Basic understanding and application of instrument, equipment and loop calibrations of various parameters in manufacturing, utilities and laboratory environments
    • Ability to climb stairs and equipment such as tanks while observing all safety considerations and requirements
    • Abe to lift moderate to heavy items
    • Understands and is aware of safety requirements and safe practices
    • Demonstrates a basic working knowledge of and can use the MS Office suite with minimal assistance 
    • Must have a valid driver’s license and good driving record
    • Reliable, confident and eager to learn and enjoys working with people
    • Able to make independent decisions within defined scope of work; seeks clarification and directions when needed
    • Self-driven; demonstrates the ability to work with little direction
    • Listens well and asks questions to learn more
    • Displays good organizational skills
    • Follows the first-in-first-out principle in choosing work and is aware of expedited calibration requirements
    • Helps maintain a turnaround time of less than 7 days and assists in maintaining supplies for laboratory day-to-day operations, such as batteries, fuses and other consumables

 

Metrologist II (in addition to those listed above)

  • Has a thorough understanding of calibration concepts and requirements including accuracy testing requirements
  • Possesses a thorough understanding and application of GXPs and Life Science industry regulations
  • Has a comprehensive understanding of instrument, equipment and loop calibrations in manufacturing, utilities and laboratory environments
  • Demonstrates effective communication and problem solving skills with clients and coworkers
  • Understands and has an in-depth working knowledge of Traceability, Substitution of Standards and Test Accuracy and Uncertainty Ratios as part of ISO 17025 requirements
  • Is able to calculate measurement uncertainties consistent with PCI’s approved uncertainty budget

 

Senior Metrologist (in addition to those listed above)

    • Demonstrates expert knowledge of instrument, equipment and loop calibrations in manufacturing, utilities and laboratory environments
    • Has exceptional Computer Maintenance Management Systems (CMMS) skills
    • Navigates and utilizes Accounting Module Pivot Table and project Key Performance Indicator (KPI) modules to support team leaders and project managers effectively manage Labor Utilization Rate (LUR), project expenses and profitability
    • Develops and updates PCI Policies and Procedures, understands and interprets Government Regulations and instrumentation/calibration principles and provides training and guidance to Metrologist I and Metrologist II resources
    • Assists clients with development and revision of policies and procedures as necessary
    • Demonstrates excellent communication and problem solving skills with clients and coworkers
    • Has exceptional negotiation skills and significant ability to effectively influence and guide others
    • Understands the business case and has an appreciation of financial issues and profit and loss implications
    • Possesses excellent analytical skills with attention to detail while keeping strategic company goals in focus
    • Provides mentorship and is sought after by technical staff for advice in technical or professional issues, diplomacy and ethical practices 
    • Is active in PCI onboarding process
    • Provides both on the job and specialized technical training using a comprehensive working knowledge of FDA and GXP compliance, as well as NIST traceability
    • Has comprehensive knowledge of test equipment and capabilities such as tolerance requirements and 4:1 TAR and TUR
    • Is actively involved with an external professional organization (ISPE, ASQ, PDA, etc.). External certification preferred (ISA, ASQ, etc.).
    • Possesses expert level knowledge and capability with all laboratory standards and is able to provide training and guidance to associates on maximizing use of standards
    • Utilizes in-depth knowledge to provide Traceability, assist Metrologists I and II with Substitution of Standards and determination of Test Accuracy and Uncertainty Ratios as part of ISO 17025 requirements
    • Is able to evaluate all contributing factors and calculate calibration uncertainty for any calibration measurement
    • Provides training to Metrologist I and Metrologist II to enable calculation of measurement uncertainties consistent with PCI’s approved uncertainty budget

 

Experience & Education Required for Sr Metrologist:

A four-year degree in Life Sciences, Engineering, Electronics, other related technical field or equivalent military training and four plus years of applicable (Metrology, Instrumentation, Calibration) experience or the equivalent combination of education and experience.  Quality System/Pharmaceutical experience is required.

PCI is proud to serve pharmaceutical, biotechnology, medical device, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions.  At PCI, calibrations are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2005. PCI is an FCX Performance Company and a Subsidiary of Applied Industrial Technologies (NYSE: AIT); a leading industrial distributor that offers more than 6.5 million parts to serve the needs of MRO and OEM customers in virtually every industry.

Applied® provides engineering, design and systems integration for industrial and fluid power applications, as well as customized mechanical, fabricated rubber and fluid power shop services. Applied also offers storeroom services and inventory management solutions that provide added value to our customers.

 

We are an equal employment opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, gender, sexual orientation, age, disability, protected veteran status, marital status, medical condition or any other characteristic protected by law.