| 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:
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