Senior Computer System Validation Consultant

Job Title: Senior Computer System Validation Consultant
Location: San Diego, CA
Type: 6 month contract
Compensation: $78-84.50/hour, depending on qualifications
Contractor Work Model: Onsite – onsite
Hours: 40.0

Overview
We are seeking an experienced Senior Computer System Validation Consultant to support and enhance a GxP-compliant Computer System Validation (CSV) program within a regulated life sciences environment. This consultant will provide Quality Assurance leadership and technical validation expertise across computerized systems supporting laboratory, manufacturing, and quality operations, ensuring compliance with FDA, EU, and GAMP 5 requirements.

Responsibilities

• Lead the enhancement and maintenance of the site's Computer System Validation (CSV) program, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Create, review, and approve validation deliverables including validation plans, risk assessments, user requirements specifications, configuration and design specifications, test scripts, and validation summary reports.
• Perform requalification of existing systems and support periodic reviews to maintain validation status.
• Oversee system development, deployment, and monitoring processes to ensure compliance at all lifecycle stages.
• Act as the Quality Lead for validation project teams, ensuring validation activities align with regulatory and company standards.
• Collaborate with cross-functional teams including IT, Engineering, Manufacturing, and Quality Control to ensure data integrity and system security.
• Support audit readiness activities and participate in internal and external inspections, including FDA and EMA audits.
• Evaluate legacy systems for integration and compliance, performing risk assessments and recommending remediation strategies.
• Drive continuous improvement initiatives to enhance quality compliance procedures and foster a collaborative, patient-first culture.

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related discipline, or equivalent experience.
• Minimum of 8+ years of experience in the Life Sciences industry with a focus on Computer System Validation and Quality Compliance.
• Expert knowledge of FDA 21 CFR Part 11, 210/211, 820; EU EudraLex Volume 4 (Annex 11 and Chapter 4); GAMP 5; and data integrity principles.
• Strong IT/technical background with familiarity with GMP systems including EDMS, LMS, LIMS, and MES.
• Proficiency in core Quality systems such as Change Control, Deviations, CAPA, Document Control, and Training.
• Excellent written and verbal communication skills, with experience authoring SOPs and validation documents.
• Ability to manage multiple projects in a fast-paced environment and work independently or collaboratively.
• Ability to lift up to 20 pounds as needed.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific