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"Know anyone for this job? CSV Subject Matter Expert(LIMS-EMPOWER) 229 in Lancaster, PA CSV Subject Matter Expert Contract Position-30 Months Send resumes to: bciociola@covexllc.com Work with the site engineering, laboratory systems leads, laboratory management, CSV assessors, and auditors to identify, assess, and remediate legacy laboratory systems. • Develop standard template to ensure effective and efficient CSV • Work with QSE-12 team to remediate laboratory system gaps • Assist in maintaining laboratory systems in a validated state as they relate to GxP CSV automation systems. • Assist with execution of validation protocols Education: BS in Technology related field Experience/Technical Competencies: • 3 to 5 years in pharmaceutical engineering, focusing on Computer System Validation. • 3 to 5 years with pharmaceutical validation experience. LIMS and EMPOWER system experience is preferred. Job Knowledge/Skillsets: • Experience with Pharmaceutical Engineering, specializing in Computer System Validation. • Familiar with GxP systems. • Fluent knowledge of GAMP 5, CFR Part 11 Compliance and CFR Part 210, 211 & 820 compliance. • Independent worker • Strong organizational/ facilitation/communication skills. • Strong verbal, written and presentation skills. • Strong skills in Interdependent partnering and influencing. Travel: <10% http://bull.hn/l/O8T9/5" |
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Friday, July 13, 2012
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