CSV & CQV

JC Automation Corp • Gurabo, PR

3d

About The Position

We are seeking experienced Computer System Validation (CSV) and Commissioning, Qualification & Validation (CQV) professionals to support a high-priority automation and computerized systems program within a cGMP pharmaceutical manufacturing environment. Resources will contribute to the full validation and qualification lifecycle for critical manufacturing systems. In this role, you will author and execute validation deliverables, lead change control activities, perform Data Integrity assessments, and support commissioning and equipment qualification. Strong regulatory knowledge, excellent documentation discipline, and the ability to work independently within an established quality system are essential.

Requirements

• Bachelor's degree in Engineering (Computer, Electrical, Mechanical, Chemical), Life Sciences, or a related technical discipline.
• Minimum 2–4 years of experience authoring and executing CSV or CQV deliverables in a pharmaceutical or biotech GMP environment.
• Demonstrated experience with full CSV lifecycle documentation — URS, Design Specs, IQ/OQ/PQ, Traceability Matrix, Risk Assessment, Summary Reports.
• Experience generating and presenting change controls in a formal pharmaceutical quality system.
• Working knowledge of Data Integrity principles and ALCOA++.
• Bilingual in English and Spanish (oral and written)

Responsibilities

• Actively participate in team meetings to provide input on project timeline considerations, activities, escalations, and status of assigned tasks.
• Execute Computer System Validation and Commissioning & Qualification activities for computerized systems, equipment, facilities, and utilities, including commissioning support and qualification activities such as Validation Plans, Security Plans, Administration and Operational SOPs, Installation and Operational Verification, Test Summaries, Risk Assessments, Master Document Lists, Traceability Matrices, Disaster Recovery Plans, Business Continuity Plans, Performance Qualification, System Inventory Lists, Source Code Reviews, User Requirements, and Design Specifications.
• Support commissioning and qualification activities for GMP facilities and utilities, including installation verification, functional testing, system turnover, punch list resolution, and applicable IQ/OQ/PQ documentation.
• Develop and revise controlled procedures in alignment with current regulatory expectations and site quality systems.
• Perform Data Integrity assessments and support remediation activities for computerized systems.
• Lead change control meetings, generate change control documentation for computer system validation and equipment qualifications, and present changes to the Change Control Review Board.
• Support external system connectivity installation and operational verification.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level