Job Description

Job Description

Job Description

Computer Systems Validation Specialist- Simply Biotech

OVERVIEW

 

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.

 

Immediate opening for a Computer Systems Validation Specialist with a biotech company in San Diego, CA who possesses:

• 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

Job Tags

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