Validation Engineer III

Title: Validation Engineer III

Location: Plano, TX

Duration: 12 Month

Job Description:

The Software Validation Engineer role responsibilities include validating computerized systems used in the R&D laboratory and in Manufacturing to ensure compliance with regulations/standards such as GAMP 5, FDA 21 CFR Part 11 and IEEE 1012. Furthermore, this role requires identifying process improvement opportunities and collaborating with cross-functional teams during validation projects.

Duties / Responsibilities

• Validate computerized systems used in R&D laboratories and Manufacturing to ensure compliance with regulatory standards (GAMP 5, FDA 21 CFR Part 11, IEEE 1012).
• Perform risk‑based validation of non‑product software used in design, testing, manufacturing, and quality system workflows.
• Define intended system use, conduct risk/impact assessments, and determine appropriate validation rigor.
• Develop validation plans, test protocols, test cases, and acceptance criteria aligned with regulatory and quality system standards.
• Execute validation activities, document results, manage deviations, and generate comprehensive validation reports.
• Review validation deliverables for accuracy, completeness, and compliance, providing feedback to cross‑functional teams.
• Investigate unexpected validation issues using systematic problem‑solving methods and communicate findings to stakeholders.
• Support troubleshooting of analytical instrument software or computerized systems as part of cross‑functional teams.
• Ensure all validation activities align with FDA regulations and GAMP 5.
• Identify process improvement opportunities, drive efficiencies, and support enhancements while maintaining compliance. 

Experience Required: 3–5 years of experience.

Experience Details

• Strong background in computerized system validation in medical devices or regulated life‑science industries.
• Solid understanding of FDA regulations (21 CFR 820, 21 CFR Part 11), GAMP 5, IEEE 1012, ISO 13485.
• Hands‑on experience developing and executing validation plans, protocols, and traceable test cases.
• Experience performing and maintaining software risk analyses, impact assessments, and documentation aligned to quality systems.
• Proven troubleshooting experience for complex software or instrument issues using structured problem‑solving.
• Strong analytical, written, and verbal communication skills.
• Experience reviewing validation deliverables and providing actionable feedback.

 Key Skills

• Computerized System Validation (CSV)
• FDA 21 CFR Part 11, 21 CFR 820
• GAMP 5, IEEE 1012, ISO 13485
• Validation plan & protocol development
• Risk assessments & impact analysis
• Test case creation & execution
• Problem solving & root‑cause analysis
• Cross‑functional communication
• Documentation accuracy & compliance

 Preferred Experience

• Experience in R&D, manufacturing, or quality system environments.
• Strong ability to drive validation investigations and lead documentation improvements.
• Bachelor’s degree preferred (Engineering, Computer Science, Life Sciences).

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

 Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.