Overview
On Site
Full Time
Skills
MVP
Computerized System Validation
GAMP
Manufacturing
Communication
GxP
Risk Assessment
RTM
Management
Root Cause Analysis
Corrective And Preventive Action
Reporting
Documentation
IQ
OQ
PQ
Requirements Traceability
Quality Management
System Documentation
AIM
Programmable Logic Controller
Hardware Troubleshooting
Regulatory Compliance
Good Manufacturing Practice
Job Details
Roles & Responsibilities:
- 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 Part 11, 210, 211, 820 as 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 Client's 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.
- Let's 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.
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