Validation and CSV Lead Engineer (Validation Lead - Capital Automation Projects)

Macpower Digital Assets Edge Private Limited

San Juan, PR

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JOB DETAILS

SALARY

$51–$51 Per Hour

SKILLS

Analysis Skills, Automation, Automation Systems, Best Practices, Capital Project, Code of Federal Regulations, Computer Systems, Cross-Functional, Data Analysis, Data Quality, Documentation, FDA (Food and Drug Administration), Functional Testing, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), GxP, ISO (International Organization for Standardization), ISO 9001, Industry Standards, Information/Data Security (InfoSec), International Electro-Technical Commission (IEC), Leadership, Maintain Compliance, Medical Equipment, Mentoring, Problem Solving Skills, Process Validation, Regulations, Regulatory Compliance, Regulatory Requirements, Risk, SAP, Software Testing, Supervisory Control and Data Acquisition (SCADA), System Integration (SI), System Validation, Team Lead/Manager, Technical Writing, Test Data, Traceability, Validation Documentation, Validation Plan, Writing Skills

LOCATION

San Juan, PR

POSTED

10 days ago

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.

About the Company

Macpower Digital Assets Edge Private Limited

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