Jobs via Dice
Computer System Validation (CSV) Engineer
Jobs via Dice, Vacaville, California, United States, 95688
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Dice is the leading career destination for tech experts at every stage of their careers. Our client, Shimento, Inc., is seeking the following. Apply via Dice today!
Computer System Validation Engineer (CSV) Location: Vacaville, CA (Onsite Role) Duration: 6‑12+ months
Key Responsibilities
Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports.
Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity.
Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations.
Provide training to stakeholders on validation requirements and best practices.
Maintain validation lifecycle documentation and change control records.
Requirements
Experience with CSV in a regulated pharmaceutical or biotech environment.
Strong knowledge of GxP, FDA 21 CFR Part 11, and EU Annex 11.
Proficiency in authoring and executing validation documentation.
Onsite availability in Vacaville, CA.
Benefits
Competitive salary: $125,528.00‑$169,832.00
Health, dental, and vision insurance.
Paid time off and flexible work arrangements.
Opportunities for professional development and career growth.
Referrals increase your chances of interviewing at Jobs via Dice by 2x.
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Dice is the leading career destination for tech experts at every stage of their careers. Our client, Shimento, Inc., is seeking the following. Apply via Dice today!
Computer System Validation Engineer (CSV) Location: Vacaville, CA (Onsite Role) Duration: 6‑12+ months
Key Responsibilities
Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports.
Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity.
Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations.
Provide training to stakeholders on validation requirements and best practices.
Maintain validation lifecycle documentation and change control records.
Requirements
Experience with CSV in a regulated pharmaceutical or biotech environment.
Strong knowledge of GxP, FDA 21 CFR Part 11, and EU Annex 11.
Proficiency in authoring and executing validation documentation.
Onsite availability in Vacaville, CA.
Benefits
Competitive salary: $125,528.00‑$169,832.00
Health, dental, and vision insurance.
Paid time off and flexible work arrangements.
Opportunities for professional development and career growth.
Referrals increase your chances of interviewing at Jobs via Dice by 2x.
#J-18808-Ljbffr