Metrology Process Lead

Full Time
Clayton, NC 27527
Posted
Job description

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.


In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.


What we offer you:

  • Leading pay and annual performance bonus for all positions
  • All employees enjoy generous paid time off including 14 paid holidays
  • Health Insurance, Dental Insurance, Vision Insurance – effective day one
  • Guaranteed 8% 401K contribution plus individual company match option
  • Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
  • Free access to Novo Nordisk-marketed pharmaceutical products
  • Tuition Assistance – reimbursement up to $10,000 annually
  • Life & Disability Insurance
  • Employee Referral Awards


At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.


Position Purpose

Improve & support the safe & effective completion of calibrations. Support troubleshooting, problem solving, & project implementation for measuring equipment at DFP Site Clayton. Ensure compliance with cGMPs as well as local & corporate requirements for calibration compliance.


Accountabilities

Will be assigned based on the following categories of tasks. Employees may be assigned to one or more of the following areas.


Advanced Calibration Accountabilities:

  • Leads, conducts, & participates in systematic problem solving. Supports cross-functional investigations in all customer areas
  • Evaluates measuring equipment performance & effectiveness of tasks & frequencies; responds to potential issues
  • Reviews documentation for accuracy & completeness & performs Technical Completion (TECO) of work orders in SAP
  • Owns continuous improvement & equipment reliability plans. Provides coaching & support to metrology technicians & process owners for measuring equipment. Owns Change Requests (CRs) & CR actions as assigned
  • Accurately performs complex mathematical formulas relating to calibrations
  • Writes & maintains standard work for calibration methods
  • Designs/Re-designs/Evaluates/Optimizes metrology systems & equipment
  • Supports &/or executes engineering studies & qualification testing for measuring equipment
  • Performs complex calibrations in the areas of temperature, pressure, conductivity, humidity, pH, TOC, flow, mass & frequency. Maintains critical metrology equipment & tools
  • Attains & maintains certification as 4P Shop Floor Trainer
  • Attains & maintains aseptic gowning certification


Planning & Quality Accountabilities:

  • Leads Shutdown preparation in close collaboration with Shutdown Manager including planning, resource allocation & execution
  • Maintains SAP master data & maintenance plans for calibration activities
  • Writes procedures & SOPs for planning calibrations & repairs on measuring equipment in the areas of temperature, pressure, conductivity, humidity, pH, TOC, flow, mass & frequency
  • Schedules calibration activities using SAP in collaboration with Logistics Planning. Assists in department planning
  • Reviews calibration documentation for accuracy & completeness & performs Usage Decisions
  • Identifies & handles deviations per proper procedures for measuring equipment. Owns Nonconformities & CAPAs as assigned


Standardization & Continuous Improvement Accountabilities:

  • Develops work packages & creates plans to support metrology technicians to include required documents, parts, & specialized tools or equipment
  • Leads calibration activities as scheduled, supported by the Supervisor. Prioritizes & leads unplanned calibration activities based on business need
  • Process confirms calibration activities are performed per standards. Responsible for annual SOP process confirmation of Metrology Procedures
  • Supports Metrology Specialists in developing new or improved calibration methods & procedures
  • Ensures team members are trained to the standard. Monitors performance & the completion of training to assure the competency level of work cell team members


All employees in this job are accountable for the following:

  • Addresses safety, quality, staffing, or personnel issues & escalates to Supervisor if necessary
  • Owns KPI’s or contributes to KPI reporting
  • Provides performance review input for work cell team members as requested by Supervisor
  • Performs the tasks of Metrology Supervisor under the direction of the Supervisor as assigned
  • Other accountabilities as assigned


Required Qualifications

  • Associates Degree or equivalent industrial, military, or vocational training
  • 7-10 years relevant metrology/calibration work experience in pharmaceutical or other highly regulated industries
  • Experience using electronic calibration management systems such as SAP, Blue Mountain RAM, ProCal, MAXIMO, etc.
  • Demonstrates a high level of organization in task management
  • Documents problems thoroughly and accurately and brings them rapidly to solution


Desired Qualifications

  • Proficiency in the following areas: Metrology, Instrumentation & Controls, Electro-Mechanical systems, & Electronics
  • Calibrate the following parameters: temperature, pressure, conductivity, humidity, pH, TOC, flow, mass & frequency
  • Able to read & apply schematics, wiring diagrams & other technical documents
  • Working knowledge of Microsoft Office applications
  • Demonstrates logical planning for task execution and follow-up
  • Demonstrates a systematic approach to problem solving and troubleshooting


Physical & Other Requirements

  • Ability to lift up to 60 lbs. with assistance
  • Ability to work in confined spaces and near operating equipment
  • Ability to attain and maintain clean room gowning certification
  • Ability to work hours necessary to support shift production
  • Corrected vision to 20/30


We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.


At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.


If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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