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Pharmaceutical Validation Engineers, Various Locations
Location: Kenosha, WI
Job Code: 14
# of openings: 1

Description
 
 
Pharmaceutical Validation Engineer

Status: Contractor position: Full-time/Temporary
Assignment duration: Approximately 6 – 12 months
Targeted start date: TBD
Location:Various Locations 
Travel: Daily commute or relocation to the client job location is required for the duration of the assignment.
Report to: Project Manager

Description:
Conducts validation activities for systems/processes by generating validation related documents, executing validation protocols, and summarizing test results. VE usually is the owner of the small validation project within a large validation effort. VE raises any issues or risks identified to Sr. VE; minimum 4 years experience.
Responsibilities:
·         Proficient in developing and writing FDS, RTM, IQ, OQ, and PQ
·         Ability to coordinate and execute validation activities
·         Strong understanding of process validation methodology
·         Good problem solving skills
·         Good technical writing skills
·         Ability to communicate with client management as well as engineer and hourly staff
·         Strong pharmaceutical manufacturing background (especially aseptic processing)
·         Basic knowledge and understanding of QSR, GDP’s and GMP’s
·         Understanding of test method validation and statistical tools
·         Prefer experience in facility and utility qualifications
·         Experience with cleaning validations
·         Experience with risk analysis 
Requirements:
  • BS or MS education, preferably with an Engineering background
  • Minimum 4 years experience
  • Knowledge of the pharmaceutical or biotechnology industry sectors and a background in FDA compliance is required

 





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