Company: NES Fircroft
Skills: Manufacturing Engineering
Experience: 4 + Years
Education: Bachelors/3-5 yr Degree
Employment Type: Full Time Contractor
Salary: Competitive
Location: Albany, New York, United States


Position Summary:

The Validation Engineer is responsible for development and execution of validation and commissioning protocols for Automated Control Systems Qualification. The position requires general equipment knowledge, cGMP, and GDP.


Duties:

Validation Engineer 
  • Perform and support execution of validation protocols/projects
  • Develop, review, and redline URS/FRS/DDS
  • Support change management process
  • Support project level customer communications and coordination efforts
  • Prepare and execute commissioning documents
  • Prepare and execute IOQ documents and summary reports
  • Maintain project lifecycle documentation in accordance with internal procedures and client procedures

Qualifications:


  • Bachelor's degree in engineering, science, or related field
  • Four to Ten (2-5) years of experience in in Biotechnology or Pharmaceutical GMP environment
  • Familiar with basic automated control systems and knowledge of PLC/HMI SCADA systems
  • Familiarity/Experience with Yokogawa data acquisition and monitoring systems a plus
  • Familiarity with Data Integrity principals for Electronic Records and Signatures per 21CFR Part 11
  • Demonstrated experience with commissioning and qualification in a pharmaceutical environment
  • Must possess a solid understanding of FDA validation guidelines, GDP, and industry best practices and be able to implement validation standards daily
  • Demonstrated experience writing and executing qualification protocols and generated summary reports.
  • Excellent organizational and communication/people skills


 

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.