Job Description

Our client is someone you know but you just didn't know it, they are a global chemical manufacturer. Their materials are so versatile and adaptable, they have virtually unlimited applications just about anywhere imaginable, making them part of daily life. Our client is currently seeking a Senior Computer System Validation (CSV) Specialist at the site in San Diego, CA.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• responsible of leading the implementation of lab instrument, manufacturing equipment and enterprise systems onsite.
• Building strong cross-functional relationships throughout the organization and translating requirements into CSV project.
• Supporting internal/external audits and other computer system lifecycle activities as required for the CSV program, as well as be responsible to develop and execute CSV lifecycle related deliverables with minimum supervision.
• Leading the periodic review of validation computerized system and generate a periodic review report.
• Supporting system owner on other computer system compliance activities like audit trail review, security review, and annual backup restore testing.
• The Senior CSV Specialist will support global computer system validation project from the Global Bio-digital Solution team and provide Veeva QMS/EDMS/Training Vaults administration as required.
• Leading implementation of computerized system and perform CSV validation activities per WBU procedure.
• Perform CSV lifecycle activities including periodic review, audit trail review, security review, backup restore testing and other activities defined per WBU SOP.
• Support global computer system implementation and validation.
• Provide CSV support in deviation, CAPA, Change Control, and computer system vendor evaluation.
• Support regulatory filings and inspection as CSV SME.
• Support CSV remediation activities from external and internal audit.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• 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%.
• Proficient understanding of GMP, GAMP, Annex 11, 21CFR
• Lead and implement CSV project with minimum supervision.
• 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.
• Implementing change initiatives and leading change.
• Statistical analysis
• Excellent analytical interpretation skills
• Risk-based application of validation principles
• Committed to delivering high quality results, overcoming challenges, focusing on what matters
• 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.

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