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Validation Engineer III CV-SIP

Company: Insight Global
Location: boulder
Posted on: May 3, 2021

Job Description:

An employer is looking for a Validation Engineer II/III in the Boulder, CO area. This candidate will be responsible for: Authorizing, reviewing and executing validation protocols in conjunction with engineering, manufacturing and QA personnel. Perform qualification of facilities, clean utilities, manufacturing and analytical equipment to demonstrate that the equipment is fit for its intended use. Perform and review SIP and autoclave cycle performance qualifications. Apply validation/engineering concepts and company procedures to generate validation protocols and reports. Follows URS documents to determine test scripts and acceptance criteria. Investigate, resolve and close deviations and associated CAPAs. Provides technical review of validation deliverables and develops final summary reports. Take ownership of production systems from a validation perspective and perform impact assessment for change control, assist in investigations and CAPA. Minimum Requirements- BS Degree in Life Sciences, Engineering- 5+ years' related experience- Previous experience in a regulated pharmaceutical, biotechnology or medical device environment- Working knowledge of system validation "life cycle" concept- Experience performing temperature mapping activities and using the Kaye Validator and ValProbes systems- Knowledge of qualification protocols (IQ, OQ, PQ)

Keywords: Insight Global, Boulder , Validation Engineer III CV-SIP, Other , boulder, Colorado

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