Job Summary: We are seeking an experienced Validation Lead to oversee the validation of major capital automation projects. The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with SCADA and SAP systems. A background in the medical device industry is preferred. Key Responsibilities:
Lead validation activities for major capital automation projects, ensuring compliance with industry regulations and best practices.
Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Ensure adherence to GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
Maintain compliance with regulatory standards, including FDA 21 CFR Part 11, ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security).
Oversee Computer System Validation (CSV) processes, including risk-based validation, system integration, interface testing, and data integrity assessments.
Collaborate with cross-functional teams to validate automation systems, including SCADA and SAP.
Prepare and maintain validation documentation, including protocols, reports, traceability matrices, and deviation records.
Ensure compliance with regulatory requirements specific to the medical device industry.
Required Qualifications:
Minimum 5 years of experience leading the validation of major capital automation projects.
4-7 years of experience in the medical device industry and associated regulations.
Strong knowledge of validation lifecycle management, including IQ, OQ, PQ, FAT, and SAT.
Proven expertise in Computer System Validation (CSV), including software testing, system integration, and documentation.
Familiarity with SCADA and SAP for system validation.
Excellent technical writing and documentation skills.
Ability to work in a regulated environment and ensure compliance with industry standards.
Preferred Qualifications:
Experience in medical device industry validation.
In-depth understanding of risk-based validation methodologies.
Strong problem-solving and analytical skills.
Ability to lead and mentor teams in validation activities.
Numbers & Facts
Location
San Juan, PR
Salary
$51 Per Hour
Skills
Analysis Skillsunmatched
Automationunmatched
Automation Systemsunmatched
Best Practicesunmatched
Capital Projectunmatched
Code of Federal Regulationsunmatched
Computer Systemsunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Data Qualityunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
Functional Testingunmatched
GCP (Good Clinical Practices)unmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
ISO (International Organization for Standardization)unmatched
ISO 9001unmatched
Industry Standardsunmatched
Information/Data Security (InfoSec)unmatched
International Electro-Technical Commission (IEC)unmatched
Leadershipunmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Mentoringunmatched
Problem Solving Skillsunmatched
Process Validationunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Riskunmatched
SAPunmatched
Software Testingunmatched
Supervisory Control and Data Acquisition (SCADA)unmatched
System Integration (SI)unmatched
System Validationunmatched
Team Lead/Managerunmatched
Technical Writingunmatched
Test Dataunmatched
Traceabilityunmatched
Validation Documentationunmatched
Validation Planunmatched
Writing Skillsunmatched
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