Company: NES Fircroft
Skills: Laboratory Ops / Tech, 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 execution of validation and commissioning protocols for laboratory equipment.  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 report
  • 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 Equipment Qualification in Biotechnology or Pharmaceutical GMP environment
  • Experience with laboratory Equipment is a must - Demonstrated Experience writing and executing qualification protocols for Lab Equipment and generating summary reports
  • Must possess a solid understanding of FDA validation guidelines, GDP, and industry best practices and be able to implement validation standards daily
  • Familiar with various analytical equipment used in pharmaceutical QC labs
  • Experience with change control process in pharmaceutical industry
  • Working knowledge of 21CFR 210, 211 and Part 11
  • Experience with Data Integrity Requirements for Electronic Records and Signatures per 21CFR Part 11
  • 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.