Computer System Validation

*Overview*

Synerlution is seeking a Computer System Validation (CSV) Specialist with hands-on DeltaV experience to support validation activities in pharmaceutical and regulated manufacturing environments in Puerto Rico.

This role will support the computerized system validation lifecycle, including the preparation, review, execution, and management of validation documentation. The ideal candidate combines practical experience validating DeltaV systems with strong technical writing, documentation, and coordination skills.

*Key Responsibilities*

* Prepare, review, revise, and maintain CSV lifecycle documentation for DeltaV and associated computerized systems.
* Develop and execute validation deliverables, including validation plans, risk assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), traceability matrices, and validation summary reports, as applicable.
* Review user requirements, functional specifications, and design specifications to ensure requirements are clear, testable, and traceable.
* Perform and document testing of DeltaV functionality, including process controls, alarms, interlocks, user access, and electronic records, as applicable to the system scope.
* Record test results, compile supporting evidence, document discrepancies, and coordinate resolution and retesting.
* Organize and manage validation documentation, including version control, review and approval workflows, and document completeness.
* Assess system changes and support change control activities, including validation impact assessments and updates to affected documentation.
* Collaborate with Automation, Engineering, Manufacturing, Quality Assurance, and IT teams to coordinate validation activities and resolve technical or documentation issues.
* Support periodic reviews and maintenance of the validated state of computerized systems.
* Perform activities in accordance with site procedures, GMP requirements, data integrity principles, and applicable regulatory requirements.

*Qualifications*

* Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.
* 2–5 years of relevant CSV experience in pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environments.
* Experience supporting DeltaV upgrades, system changes, or integration with other manufacturing systems.
* Familiarity with DeltaV batch functionality and recipe-related validation.
* Demonstrated experience preparing, reviewing, and executing CSV protocols and managing validation lifecycle documentation.
* Working knowledge of GAMP 5 principles, risk-based validation approaches, 21 CFR Part 11, and data integrity principles.
* Experience documenting test evidence, managing discrepancies, and maintaining requirements traceability.
* Strong technical writing, organizational, troubleshooting, and communication skills.
* Ability to manage assigned deliverables independently while collaborating with multidisciplinary teams.
* Availability to work on-site in Puerto Rico.

Submit your resume highlighting your DeltaV validation experience, CSV lifecycle responsibilities, and experience developing and managing validation documentation.

_Synerlution is an equal opportunity employer._

Education:
* Bachelor's (Required)

Experience:
* DeltaV: 3 years (Required)

Shift availability:
* Day Shift (Preferred)
* Night Shift (Preferred)

Ability to Commute:
* Carolina, PR * (Required)

Work Location: In person