Role Summary
The Software and Process Validation engineer is responsible for ensuring that computerized systems, manufacturing processes, equipment, utilities, facilities, and associated quality systems consistently perform as intended and comply with regulatory, quality, and business requirements. This role supports the full validation lifecycle, including planning, risk assessment, qualification, testing, documentation, change management, and maintenance of the validated state.
Key Responsibilities
- Lead software validation for new systems and changes, including requirements, risk assessments, testing, traceability, deviations, reports, integrations, and data migrations.
- Support audits, inspections, and quality investigations
- Perform validation risk assessment utilizing the appropriate risk-validation and CSA principles
- Evaluate data integrity, access controls, audit trails, electronic records and signatures, security, backup and recovery, and continued validated-state requirements.
- Support process and equipment validation, including IQ/OQ/PQ, PPQ, cleaning, utilities, facilities, technology transfer, and new product introduction.
- Apply change control, CAPA, deviation, document-control, and risk-management requirements; monitor milestones, escalate risks, and support audits and inspections.
- Lead validation of GxP computerized systems.
- Develop and execute validation plans.
- Create and review: URS, risk assessments; traceability matrices; test scripts and validation reports.
- Assess data integrity controls, audit trails, electronic records, and electronic signatures.
- Support software implementations, upgrades, integrations, cloud applications, and system changes.
Required Qualifications
- Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, Quality, or a related technical field.
- At least 3 years of validation, quality engineering, quality systems, software quality, or related experience in a regulated environment.
- Hands-on computerized system validation experience covering requirements, risk assessment, testing, traceability, deviations, and validation reporting.
- Working knowledge of GxP/cGMP, FDA, ISO, data integrity, change control, CAPA, technical writing, and project execution.
Preferred Qualifications
- Experience validating enterprise eQMS, laboratory, manufacturing, ERP, cloud/SaaS, reporting, integration, or data-migration solutions.
- Experience with process/product validation, equipment, facilities and utilities qualification, cleaning validation.
- Knowledge of ISO 9001, cGMP, FDA 21 CFR Parts 11, 210, 211, 820, Health Canada, ICH, Pic/s guidance, MHRA Data integrity
- Multilingual communication capability, preferably English plus Spanish or Portuguese, and willingness to travel to manufacturing locations
