Senior Computer Systems Validation Specialist Job at Thorough Group, San Diego, CA

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  • Thorough Group
  • San Diego, CA

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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