U.S. VALIDATION SERVICES LLC JOBS
Careers
US Validation Services LLC is looking for Entry Level Validation Engineer and Senior Level Validation Engineer to perform qualification of equipment and utility systems. We have 6 -- 12 month project in Boston area where we are assisting our pharmaceutical client.

Please send us your resume to: JOBS@USVALIDATION.COM

Please note that U.S.Validation Services LLC is not sponsoring H1B visa program. Authorization to work in Unites States is Required.

ENTRY LEVEL VALIDATION ENGINEER:
Job Description:
  • Execute previously approved Qualification Protocols and provide support during protocol executions.
  • Setting up Temperature Data Acquisition equipment (KAYE Validator)
  • Perform Temperature Mapping studies for Environmental Chambers
  • Collect and Analyze data accumulated during temperature mapping studies
  • Draft Summary Reports and applicable protocol amendments.


Qualifications:
  • BS in chemical, biomedical, or mechanical engineering or relevant discipline
  • Recent graduates, interns and coop students are welcome
  • Ability to learn regulated by FDA production environment.
  • Strong technical skills - ability to operate equipment and setup thermocouple wires
  • Strong technical writing and documentation skills are required.
  • Must demonstrate strong interpersonal and teamwork skills.
  • Authorization to work in Unites States is Required.
  • Ability to work in a fast pace environment.

SENIOR VALIDATION ENGINEER:
Job Description:
  • Write Qualification protocols (IQ/OQ/PQ) for Equipment and Utility Systems
  • Develop User Requirements and Functional Specifications
  • Author Summary Reports and applicable protocol amendments.
  • Execute Qualification Protocols and/or provide support during protocol executions.
  • Write and investigate Discrepancies and Deviation Reports which occurs during execution of the Qualification Protocols
  • Assure all the qualification items are tracked and successfully completed.
  • Coloborate with Metrology department to assure that all instruments related to equipment are in calibrated state during execution of the protocols.
  • Develop Operation and Preventative Maintenance procedures at client's request


Qualifications:
  • BS/MS in chemical or mechanical engineering or relevant discipline
  • 5 to 7 years of experience working within cGMP regulated production environment.
  • Must have a working knowledge of cGMP type systems and practices (21CFR Part 210 and 211 and ICH Q7)
  • Strong technical writing and documentation skills are required.
  • Must demonstrate strong interpersonal and teamwork skills.
  • Authorization to work in Unites States is Required.
  • Ability to work in a fast pace environment.