Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Computer System Validation Specialist
The CSV resource will provide risk-based validation services for Factorian and L7 ESP and for other GxP computerized systems assigned by the Company.
- Review intended use, GxP impact, system architecture, supplier documentation, configuration or customization, interfaces, data flows, infrastructure dependencies, and existing SDLC evidence to define the validation approach and identify gaps.
- Develop, revise, execute, and close applicable lifecycle documents, including GxP and electronic records assessments, Validation Plans, User Requirements Specifications, Functional or Design Specifications, risk assessments, supplier assessments, test protocols or scripts, Requirements Traceability Matrices, discrepancy records, Validation Summary Reports, and release documentation.
- Evaluate and test applicable controls for user access, roles and permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time synchronization, backup and recovery, data migration, security, and system administration.
- Execute approved testing in the authorized environment, capture attributable and traceable objective evidence, manage test incidents and deviations, coordinate corrective actions and retesting, and maintain requirements-to-test traceability through closure.
- Ensure changes and releases for Factorian, L7 ESP, and other validated systems are governed through Change Control and that required validation, procedural, training, data, and operational readiness activities are complete before release.
- Document development and approved remote testing may be performed remotely when authorized.
- On-site work in Aguadilla is required when system access, integration testing, instrument connectivity, or execution activities cannot be adequately performed remotely.
Scope of Work:
The assigned qualification resource shall perform the following activities for each system or equipment item included in the approved assignment:
- Review the applicable User Requirements Specification, design documents, drawings, vendor manuals, commissioning records, calibration records, certificates, approved risk assessments, and other available lifecycle documents.
- Confirm the qualification boundary, system components, prerequisites, test strategy, acceptance criteria, and documentation needed to support protocol development and execution.
- Perform field walkdowns and document reviews needed to confirm that the system is ready for qualification.
- Generate an IQ/OQ protocol using the current Company procedure, template, and document control process.
- Incorporate review comments and support protocol routing until the protocol is approved for execution.
- Execute the approved IQ/OQ protocol in accordance with the Company procedures and Good Documentation Practices.
- Document discrepancies, exceptions, and deviations identified during execution and provide the technical information needed for assessment and resolution.
- Coordinate retesting after approved corrective actions when retesting is within the assigned scope and authorized hours.
- Assemble the executed protocol and supporting evidence into a complete package suitable for review and approval.
- Generate and maintain the Requirements Traceability Matrix linking applicable requirements to qualification tests and objective evidence.
- Generate the Qualification Summary Report describing the scope performed, results, deviations, open items, and conclusion on system qualification status.
- Support review comment resolution and final approval of the executed protocol, Requirements Traceability Matrix, and Qualification Summary Report.
- Maintain an accurate weekly forecast, deliverable tracker, and time record for the assigned work.
Qualifications:
- Bachelor's degree in Engineering or related field.
- Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests for the specific service area proposed.
- Prior experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
- Working knowledge of applicable GMP regulations, Good Documentation Practices (GDP), regulatory guidance, data integrity principles, risk-based qualification and validation, and industry standards relevant to the assigned scope, including FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles.
- Ability to interpret User Requirements Specifications, design documents, drawings, functional specifications, control narratives, vendor documentation, calibration records, and commissioning evidence.
- Demonstrated ability to write clear qualification or validation documents and reports and to execute testing accurately in the applicable field or computerized environment.
- Strong written and verbal communication skills in English. Spanish proficiency is preferred for effective site interaction.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.