Urgent Need Validation Support Engineer C2C jobs Onsite || Johns Creek, GA

Position: Validation Support Engineer
Location:  Johns Creek, GA
Contract

Job Description:

Beckhoff TwinCAT PLC experience will be a big plus, and we must look for it in the proposed candidate. Let’s aim for 5-8 yrs experience.

1. 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 TwinCAT PLC-controlled systems within a 24/7 medically regulated facility. This includes validation of new/modified EtherCAT 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.

2. Scope of Work (1 Validation Engineer)

Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes.

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 TwinCAT 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 lifecycle documentation.

Compliance: Ensure all validation activities and documentation meet internal procedures and regulatory requirements.

3. Key Deliverables

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.

4. Engineer Profile & Responsibilities

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 TwinCAT 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.

 thanks & Regards

Mohammad Faisal