Computer Systems Validation Specialist - Simply Biotech

-Bachelor's degree in scientific discipline required, MS/Ph.D. preferred-4+ years of experience in pharmaceutical computer system validation, experience with Veeva and EDMS is a plus-Must have knowledge of GAMP 5 regulations, experience with Annex 11 and 21CFR regulations is highly preferred-Must have experience with leading the full CSV lifecycle from end-to-end, experience with CSV within manufacturing is a plus Email resumes to odrow@simplybiotech.com or call 858.866.8676

FULL DESCRIPTION: The selected candidate will be responsible for: -Develop and execute computer system validation deliverables including but not limited to URS, FRS, Risk Assessment, Design Specification, IQ/OQ/PQ, RTM and Validation Summary Report.-Support global computer system implementation and validation.-Lead computer system validation activities in WBU site.-Ensure computer systems in WBU site are compliance with CSV SOPs.-Provide CSV support in deviation, CAPA, Change Control, and computer system vendor evaluation.-Perform periodic review for computer system used in WBU site.-Support regulatory filings and inspection as CSV SME.-Support CSV remediation activities from external and internal audit.

The selected candidate will also possess: -Bachelor's degree in science with 6+ years or MS/PhD with 4+ years of GMP/Relevant Industry Experience. (Chemistry, biochemistry, or related discipline preferred).-Must have 4+ years of experience in pharmaceutical (FDA regulated industry) computer system validation.-Ability to travel less than 10%.-GMP, GAMP, Annex 11, 21CFR knowledge and experience-Statistical analysis-Excellent analytical interpretation skills-Risk-based application of validation principles-Committed to delivering high quality results, overcoming challenges, focusing on what matters-Implementing change initiatives and leading change.-Ability to lead and implement CSV project with minimum supervision.-Strong problem solving and decision-making skills-Good organizational skills and attention to detail.-Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels.-Ability to handle multiple assignments and changing priorities.-Positive, proactive approach to drive assignments/tasks to completion.-Proficiency with Microsoft Word, Excel, PowerPoint-Ability or capable of lifting up to fifty (50) lbs.-Experience of Veeva Quality Management System and EDMS is a plus.-Must have strong hands-on, end-to-end validation experience and application of project controls / management - including familiarity with all project lifecycle phases from requirements gathering through delivery, issues / risk management, change management, release management and retirement management.-Experience with wide range of CSV experience including Manufacturing, Lab and Enterprise CSV experience.

Salary Range: $82k-100k/yr

For immediate and confidential consideration, please email your resume to odrow@simplybiotech.com or call 858.866.8676. More information can be found at www.simplybiotech.com