Validation Support Engineer
Validation Support Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes.
- Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g. GAMP5) FDA regulations (21 CFR Partas applicable) and validation of automated manufacturing/control systems.
- Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus).
- Responsibilities: Perform tasks under Scope of Work generate high-quality validation documentation adhere to the Clients quality/site protocols and maintain clear communication.
- Risk Assessment: Lead/participate in GxP risk assessments for the implemented changes.
- Protocol Development & Execution: Author review and execute Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols for the modified Twin CAT systems.
- Requirements Traceability: Develop and maintain Requirements Traceability Matrices (RTM).
- Deviation Management: Investigate document and manage deviations encountered during validation activities; support root cause analysis and CAPA development.
- Reporting: Author Validation Summary Reports (VSR) and other validation of lifecycle documentation.
- Compliance: Ensure all validation activities and documentation meet internal procedures and regulatory requirements.
- Approved Validation Plans (VPs).
- Executed IQ/OQ/PQ protocols with documented evidence and results.
- Completed Requirements Traceability Matrices (RTMs).
- Deviation reports (if any).
- Approved Validation Summary Reports (VSRs).
- Contributions to quality management system documentation as required.
- Beckhoff Twin CAT PLC experience will be a big plus and we must look for it in the proposed candidate.
- Lets aim for 5-8 years of experience.
- Overview & Objective: Alcon requires one (1) expert Validation Engineer for an 8-month engagement.
- The engineer will lead and execute validation activities for changes made to Beckhoff Twin CAT PLC-controlled systems within a 24/7 medically regulated facility.
- This includes validation of new/modified Ether CAT hardware diagnostics safety system functionalities and specification monitoring logic.
- The objective is to ensure all changes are validated in compliance with cGMP relevant regulations (e.g. 21 CFR Part 11 Part 820) and internal quality standards.
Employment Type
Full Time
