Senior Computer System Validation Consultant

Senior Computer System Validation Consultant TalentBurst, Inc. - 3.5 San Diego, CA Job Details Contract 14 hours ago Benefits Health insurance Dental insurance Vision insurance Qualifications GAMP Pharmaceutical regulatory compliance Compliance audits & assessments Bachelor's degree IT FDA regulations Engineering validation

Full Job Description Position:

Senior Computer System Validation Consultant (GxP), Req#

ROCGJP00040530

Location:

San Diego, CA (100% onsite). This is for the Poseida location in San Diego, CA.

Duration:

6+ months c ontract with high possibilities of extension

Department :

Quality Assurance Reports To:

Site Quality Head / Director, QA Hours requirement: 8 to 5; may need to have some flexibility to work earlier/later as needed

Job Description:

About Us Based in San Diego, the site operates as a clinical-stage biopharmaceutical facility utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics. Position Summary The Quality organization is seeking an exceptional consultant/contracted specialist to join our Quality team in San Diego, CA. This is an on-site role that will lead the enhancement and maintenance of the computer system validation program. As the CSV Quality SME, you will provide critical Quality Assurance oversight and technical validation expertise for computerized systems within the San Diego site and environment. Reporting to the Site Quality Head, you will ensure that all IT and automated systems—ranging from laboratory and manufacturing to quality support—are implemented, validated, and maintained in full compliance with

FDA 21 CFR

Part 11, EU Annex 11, and GAMP 5 standards.

Your Impact:

You will be an integral part of a friendly Quality Assurance (QA) Team that is dedicated, agile, and collaborative. In this on-site contracted role, you will have a direct impact in supporting the computer system validation program which supports the ongoing operations at San Diego. You will foster cross-functional collaboration while meeting assigned Quality Deliverables specific to the Computer System Validation program.

Education and Experience:

Education :

Bachelor's degree in Life Sciences discipline with the Life Sciences industry (Consulting or Industry) with a focus on CSV and Quality Compliance.

Experience :

Minimum of 8+ years of experience in the Life Sciences industry (Consulting or Industry) with a focus on Computer System Validation and Quality Compliance. Regulatory Knowledge Expert understanding of 21 CFR Part 11, GxP (211/820), GAMP 5, and EU Annex 11. Technical Background Strong IT/Technical background to understand the complexities of networked programs and infrastructure. System Tools Familiarity with laboratory, manufacturing, and quality management systems for GMP operations. Fluency in quality management systems for managing validation and change records. Soft Skills Excellent communication, collaborative attitude, and the ability to manage multiple projects in a complex environment. Complete proficiency in Excel, PowerPoint and Word. Fluency with advanced/expert knowledge in data integrity and computer systems for cell and gene therapy / biotech / pharmaceutical applications. Demonstrated ability to work independently, within prescribed guidelines, or as a team member Strong knowledge and competence in the utilization of core quality systems such as Change Control, Deviations, CAPA management, Document Control, Training, EDMS and LMS systems

Key Responsibilities:

Validation Lifecycle & Governance Deliverable Management:

Author, review, and approve critical validation deliverables, including Validation Plans, Risk Assessments, User Requirements (URS), Configuration Specifications, Test Scripts (IQ/OQ/PQ), and Validation Summary Reports. Perform requalification of existing computer systems and support periodic reviews of computer systems.

System Development Oversight:

Define and oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration.

Project Guidance:

Act as the Quality Lead for project teams, guiding the implementation of validation, security, and project management deliverables at appropriate stages of the system lifecycle.

Operational Compliance & Audit Readiness System Oversight:

Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations.

Audit & Inspection Support:

Lead or contribute significantly to internal and external audits, assessments, and compliance plans to support future Health Authority inspections (FDA/EMA).

Risk Management :

Apply thorough knowledge of risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to appropriate leadership.

Reporting :

Prepare management reports regarding compliance operations, project progress, and the overall validated state of site systems. Technical Integration & Tool Management Support evaluation of existing legacy systems for technical integration and tool management. Perform gap assessments and risk assessments on legacy systems, as required.

Security & Control:

Advise project teams on the implementation of compliance and security control requirements to ensure data integrity and system reliability are integrated by design.

Other Responsibilities:

Align daily actions with department goals and company culture Actively promote teamwork across all functions with focus on our patients being the top priority Drives, fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product #TB_PH #ZR Why TalentBurst? At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.