Company: NES Fircroft
Skills: Facilities Engineer, Laboratory Ops / Tech, Project Engineer
Experience: 10 + Years
Education: Bachelors/3-5 yr Degree
Employment Type: Full Time Contractor
Salary: Competitive
Location: Albany, New York, United States


Our client, a large Biopharmaceutical company, is urgently seeking Sr. Validation Engineers specializing in Biotech Process Cleaning Validation and Continuing Validation Monitoring of Cleaning Cycles for 6 month-1-year contracts in Albany, NY. These contracts have high potential to turn permanent.

 

Position Summary:

The Sr. Validation Engineer is responsible for Biotech Process Cleaning Validation and Continuing Validation Monitoring of Cleaning Cycles. The position requires general equipment knowledge, cGMP, and GDP.

 

Duties:

Sr. Validation Engineer (10+ years)

  • Develop and manage cleaning validation cycles and programs
  • Perform and support execution of validation protocols/projects
  • Manage a small team of engineers and provide guidance
  • Develop, review, and redline URS/FRS/DDS
  • Support change management process
  • Support project level customer communications and coordination efforts
  • Cleaning cycle development
  • Prepare, execute, review, and approve IOQ documents
  • Maintain appropriate project documentation and files in accordance with Mangan Biopharm internal procedures and client procedures
Qualifications:

  • Bachelor's degree in engineering, science, or related field (MS preferred)
  • 10+ years of experience in Equipment Qualification in Biotechnology or Pharmaceutical GMP environment with emphasis on cleaning validation
  • Experience with CIP, SIP, and Autoclave recipes, cycle development and operations is required
  • Hands-on experience in validating and qualifying equipment
  • Must possess a solid understanding of FDA validation guidelines, GDP, and industry best practices and be able to implement validation standards on a daily basis
  • Excellent organizational and communication/people skills
  • Must possess strong verbal and written skills
  • Project management experience (PMP Certification is highly desired)


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.