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Job Title: Validation Engineer (Beckhoff TwinCAT PLC)
Location: Atlanta, GA - Onsite
Duration: 8 Months
**W2 Only**
Our client is seeking Validation Engineer for an 8-month engagement to lead and execute validation activities related to Beckhoff TwinCAT PLC-controlled systems within a 24/7 medically regulated facility. This includes validating changes to EtherCAT hardware diagnostics, safety system functionalities, and specification monitoring logic. The primary objective is to ensure all changes are validated in full compliance with cGMP, applicable regulations (21 CFR Part 11, Part 820), and internal quality standards.
Responsibilities:
- Validation Planning: Develop or update Master Validation Plans (MVP) and Validation Plans (VP) for PLC system changes.
- Risk Assessment: Lead or participate in GxP risk assessments related to system modifications.
- Protocol Development & Execution: Author, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Requirements Traceability: Create and maintain Requirements Traceability Matrices (RTM).
- Deviation Management: Investigate and document deviations; support root cause analysis and CAPA activities.
- Reporting: Prepare Validation Summary Reports (VSR) and other validation lifecycle documentation.
- Compliance: Ensure all validation tasks and documentation conform to internal SOPs and regulatory requirements.
- Approved Validation Plans (VPs)
- Fully executed IQ/OQ/PQ protocols with supporting evidence
- Completed Requirements Traceability Matrices (RTMs)
- Deviation reports (as applicable)
- Approved Validation Summary Reports (VSRs)
- Updates or contributions to quality management system documentation, as required
Required Experience:
- 710 years in Computer System Validation (CSV)
- Deep understanding of GAMP5, 21 CFR Part 11, 210/211, and 820
- Extensive experience validating automated control/manufacturing systems
- Strong preference for candidates with Beckhoff TwinCAT PLC experience
Seniority level
Seniority level
Associate
Employment type
Employment type
Contract
Job function
Job function
Science, Engineering, and Product Management-
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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