Computer System Validation Specialist

Job Summary

Synerlution is seeking a Computer System Validation (CSV) Specialist with hands-on experience managing Computer System Validation activities throughout the computerized system lifecycle in pharmaceutical, biotechnology, medical device, or other GxP-regulated environments.

The selected candidate will support and coordinate validation activities from requirements definition and risk assessment through protocol development, test execution, documentation, and ongoing maintenance of the validated state.

This role requires practical knowledge of GxP requirements, GAMP 5, FDA 21 CFR Part 11, data integrity principles, and risk-based validation approaches. The successful candidate will collaborate with IT, Engineering, Automation, Quality Assurance, Manufacturing, and system owners to ensure computerized systems remain compliant with applicable regulatory and client requirements.

This position requires direct, hands-on Computer System Validation experience. General Quality Assurance, Quality Systems, Regulatory Compliance, or GMP documentation experience alone does not meet this requirement.

Key Responsabilities

• Support and coordinate CSV activities throughout the computerized system lifecycle, including system implementation, upgrades, changes, and ongoing maintenance.
• Participate in the development and review of validation plans, system requirements, and risk-based validation strategies.
• Prepare, review, and maintain validation documentation, including User Requirements Specifications (URS), risk assessments, test protocols, traceability matrices, and Validation Summary Reports.
• Support the evaluation of system functionality, intended use, and applicable GxP requirements to determine appropriate validation activities.
• Develop, review, execute, and document validation test scripts and qualification protocols, as applicable.
• Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), according to the system and approved validation approach.
• Verify that computerized systems meet approved requirements and perform as intended.
• Document test results, maintain traceability between requirements and test evidence, and ensure validation records are accurate and complete.
• Identify discrepancies during testing and support deviation investigations, corrective actions, and resolution activities.
• Apply applicable GxP/cGMP requirements, GAMP 5 principles, and FDA 21 CFR Part 11 requirements.
• Support data integrity assessments and evaluate applicable controls for electronic records, electronic signatures, audit trails, and user access.
• Maintain validation documentation in accordance with approved procedures, regulatory expectations, and client requirements.
• Support risk assessments and compliance gap assessments for computerized systems.
• Support change control assessments to determine the impact of system modifications on the validated state.
• Participate in periodic reviews and assessments of computerized systems.
• Support the maintenance of validation records and evidence throughout the system lifecycle.
• Collaborate with cross-functional teams to address validation issues, maintain compliance, and support audit readiness.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related field; equivalent relevant experience may be considered.
• Two to four years of hands-on Computer System Validation experience in pharmaceutical, biotechnology, medical device, or another GxP-regulated environment.
• Demonstrated experience performing multiple CSV lifecycle activities, including validation documentation, risk assessments, test execution, and lifecycle maintenance.
• Practical experience developing and/or executing validation protocols and test scripts for computerized systems.
• Experience with validation deliverables such as URS, risk assessments, traceability matrices, test protocols, and Validation Summary Reports.
• Familiarity with Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), Manufacturing Execution Systems (MES), Electronic Quality Management Systems (eQMS), ERP platforms, or other GxP-relevant applications.
• Exposure to automation-related systems, including SCADA or other computerized manufacturing systems.
• Working knowledge of GxP/cGMP requirements, GAMP 5, FDA 21 CFR Part 11, and data integrity principles.
• Familiarity with change control, deviation management, regression testing, and maintenance of the validated state.
• Ability to independently execute assigned validation tasks, identify issues, and collaborate effectively with cross-functional teams.
• Strong technical writing, documentation, analytical, and problem-solving skills.

This is a 100% onsite position based in Guayama, Puerto Rico. Remote and hybrid work arrangements are not available.

Application Question(s):

• How many years of hands-on Computer System Validation (CSV) experience do you have in a GxP-regulated environment?
• Have you directly executed and documented validation tests for computerized systems?

Education:

• Bachelor's (Required)

Shift availability:

• Day Shift (Preferred)
• Night Shift (Preferred)

Work Location: In person