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Mechanical Engineer Synerfac Technical Staffing
Langhorne, PA4 days ago
- $80,000–$120,000 Per Year
- Employee
- Instant Apply
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Skills
- Artificial Intelligence (AI)unmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Code of Federal Regulationsunmatched
- Computer Scienceunmatched
- Computer Systemsunmatched
- Cross-Functionalunmatched
- Data Lakeunmatched
- Data Processingunmatched
- Data Qualityunmatched
- ERP (Enterprise Resource Planning)unmatched
- Environmental Sciencesunmatched
- GxPunmatched
- Information Technology & Information Systemsunmatched
- Maintain Complianceunmatched
- Process Validationunmatched
- Quality Assuranceunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Risk Analysisunmatched
- SAPunmatched
- Snowflake Schemaunmatched
- System Lifecycleunmatched
- System Validationunmatched
- Test Plan/Scheduleunmatched
- Test Scriptsunmatched
- Traceabilityunmatched
- Validation Documentationunmatched
- Validation Planunmatched
- Validation Testingunmatched
- Writing Skillsunmatched
Description
Summary:
IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment.
This role will focus on validating ERP Master Data Governance processes and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards.
Roles & Responsibilities:
IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment.
This role will focus on validating ERP Master Data Governance processes and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards.
Roles & Responsibilities:
- Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems
- Support validation activities for ERP Master Data Governance processes, ensuring data accuracy, integrity, and compliance
- Perform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layers
- Collaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteria
- Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle
- Support deviation investigations, CAPAs, and change control activities related to validated systems
- Maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary Reports
Education & Experience:
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline
- 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environments
- Strong experience with test script authoring and execution for GxP systems
- Experience supporting Master Data Governance processes (SAP experience preferred but not required)
- Experience validating Data Lake environments and system interfaces (Snowflake experience preferred)
- Familiarity with AI/advanced data platforms is a plus
- Experience with validation management tools such as Val Genesis is a plus
- Strong understanding of GxP, 21 CFR Part 11, and data integrity principles
- Ability to work independently and manage multiple validation activities with minimal oversight
Numbers & Facts
| Location | Somerset, NJ |
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