Automation Validation Engineer

LanceSoft Inc; Lexington (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking an Automation Validation Engineer to lead the development of an Automation Commissioning and testing program. This role involves creating guidance documents, identifying defects, and ensuring compliance with regulatory requirements. With a focus on Process Automation and Computer System Validation, the ideal candidate will have extensive experience in commissioning control systems and utilizing specialized software. This is a fantastic opportunity to contribute to vital projects that impact patient safety and product quality in a dynamic environment.

Qualifications

• 10+ years of experience in Process Automation and Computer System Validation.
• Expertise in commissioning and qualification of control systems.

Responsibilities

• Develop an Automation Commissioning and testing program.
• Create guidance documents for workflows and testing objectives.

Skills

Engineering Degree (Chemical, Computer Systems, Electrical)

Process Automation

Computer System Validation

Commissioning and Qualification of Control Systems

Code Configuration Management

Emerson Delta V

Education

Engineering Degree

Tools

Kneat Software

Job description

Job Title - Automation Validation Engineer

Duration: Expected time frame for completion: 6 to 9 months

Location: Lexington, MA – 02421

Responsibilities

1. Develop an Automation Commissioning and testing program.
2. Create guidance documents to describe workflows and provide testing objectives, including:

• Identifying defects prior to operational use
• Reducing the risk of failures affecting patient safety, product quality, or data integrity
• Demonstrating that the configured change meets its requirements
• Providing evidence that the system is fit for its intended use
• Offering a basis for user acceptance
• Meeting key regulatory requirements
• Ensuring effective risk management controls

Provide guidance for workflow stages such as:

• Test Planning and Coverage
• Test Management Processes
• Test Cases
• Test Execution
• Reviewing and Reporting of tests

Utilize Kneat software and develop standard testing templates (planning, test cases, final reports).

Skills Required

• Engineering Degree (Chemical, Computer Systems, Electrical)
• Minimum of ten years of experience
• Focus on Process Automation and Computer System Validation
• Experience in commissioning and qualification of control systems
• Experience with code configuration management and commissioning
• Experience with Emerson Delta V