Computer Systems Validation (CSV) and Data Integrity Specialist

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

 

SUMMARY
§ CSV & Data Integrity Specialist will ensure that all GxP relevant computerised systems are validated in accordance with applicable regulatory requirements (e.g. EU GMP Annex 11, FDA 21 CFR Part 11) and that data integrity principles are embedded throughout the lifecycle of these systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

· Lead and execute validation activities for new and existing GxP computer systems onsite. This includes

completing Software and 21 CFR Part 11 assessments.

· Develop and maintain validation documentation including Risk Assessments, Validation Plans, IQ/OQ/PQ

Protocols and Reports as per site and corporate procedures.

· Collaborate with cross-functional teams (QA, IT, Engineering, Projects) to ensure validation deliverables are

aligned with project timelines.

· Ensure computer systems are maintained in a validated state throughout their lifecycle.

· Reviewing updates to regulatory guidelines for electronic data systems to ensure ongoing compliance.

· Coordinating the needs of functional areas and establishing priorities for electronic data systems including gap

analysis and remediation programs.

· Working with the IT, Automation and NPI groups on projects such as defining User Requirement Specifications

and executing test plans.

· Providing training and support on Data Integrity across site.

· Ensuring data integrity gap analysis are complete for all systems and equipment on site both new and already

in use to ensure compliance.

· Develop remediation plans / strategies if required for systems is use.

· Develop data integrity program for the site and be the site point of contact for all audits.

· Ensure continuous improvements are in place for Data Integrity

· Complete gap analysis and put solutions in place using a risk-based approach.

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MINIMUM REQUIREMENTS

· Bachelor’s degree in information technology or relevant discipline.

· Min of 5 years’ experience in CSV within a regulated industry including experience of implementing Data

Integrity related controls in an Information Technology and Operational Technology environment.

· Strong understanding and extensive knowledge of CSV and Data Integrity related regulations

· Experience with risk-based validation approaches (e.g. GAMP 5)

Skills and Attributes:

· Excellent accuracy and attention to detail

· Excellent communication and interpersonal skills to communicate well, both verbally and in writing.

· Excellent initiative, decision making and be able to work in a core team environment.

· Excellent time management skills.

· Desire to learn new tasks and flexibility

· Solution driven with emphasis on performance and results.

 

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Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

 

Accessibility Accommodation  

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [email protected] with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

 

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