Senior Validation Engineer

TechDigital Group; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

An innovative company is seeking a Non-Product Software Validation Engineer with a strong manufacturing background, particularly in the medical devices or diagnostics sector. In this role, you will be responsible for ensuring compliance with regulatory standards, preparing and reviewing essential documentation, and executing validation activities. This position offers a unique opportunity to contribute to critical projects that impact the quality and safety of medical technology. If you have a passion for software validation and a commitment to excellence in the manufacturing field, this is the perfect opportunity for you to make a significant impact.

Qualifications

• 6-8 years of experience in Non-Product Software Validation in manufacturing.
• Strong knowledge of FDA and ISO regulatory standards.

Responsibilities

• Execute software validation for manufacturing equipment per regulatory standards.
• Prepare and review functional requirements and validation documents.
• Prepare, review functional requirements, design and testing documents.
• Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment, installation qualification, operational qualification, performance qualification, traceability matrix, project release notes, system certification summary).
• Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP.
• Preparing trace matrix to ensure requirements are tested to meet the software intended use.
• Preparing risk assessment for functional requirement and provide testing strategy, implementing technical & procedural controls as part of mitigation.
• Preparing SOP/Work instruction for equipments and software-based systems.

Skills

Software Validation

Regulatory Standards (FDA, ISO)

Risk Assessment

Documentation Review

GAMP Knowledge

Education

Bachelor's Degree in Engineering or related field

Tools

Validation Plan Documentation

Traceability Matrix

Job description

Job Responsibilities:

1. 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics).
2. Non-Product software validation for Manufacturing Equipments as per Regulatory standards (FDA, ISO requirements).
3. Prepare, review functional requirements, design and testing documents.
4. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment, installation qualification, operational qualification, performance qualification, traceability matrix, project release notes, system certification summary).
5. Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP.
6. Preparing trace matrix to ensure requirements are tested to meet the software intended use.
7. Preparing risk assessment for functional requirement and provide testing strategy, implementing technical & procedural controls as part of mitigation.
8. Preparing SOP/Work instruction for equipments and software-based systems.