Job Description

Sr. Validation Engineer SOW 052325 2

ID SOW 052325 2

Job Type: W2 – 1-Year Contract (with potential for extension)

Location: 3348 Pulliam Street, San Angelo, TX

Pay Rate: $46.00/hr

Start Date: ASAP

🧩 Position Summary

We are seeking a Sr. Validation Engineer to ensure manufacturing equipment, processes, and laboratory systems meet rigorous medical device regulatory standards and industry expectations. The ideal candidate will have strong hands-on experience with validation methodologies, IQ/OQ/PQ execution, technical documentation, and risk management in a GMP-regulated environment.

You will play a key role in supporting the validation of new and existing equipment , developing protocols, and ensuring compliance with FDA, ISO 13485 , and other regulatory guidelines.

🔧 Key Responsibilities

• Generate equipment and fixture matrices with qualification requirements as defined by the client (MVP).
• Develop and execute detailed IQ/OQ protocols for medical device manufacturing and laboratory equipment in alignment with client specifications.
• Execute PQ validations and author completion reports following successful protocol execution.
• Troubleshoot and lead root cause investigations ; implement effective corrective and preventive actions.
• Write, review, and maintain Standard Operating Procedures (SOPs) for validated equipment and processes.
• Ensure validation deliverables are regulatory-compliant (GMP, FDA, ISO 13485, MDD).
• Manage and prioritize multiple complex validation projects simultaneously.
• Complete full validation documentation lifecycle (IQ, OQ, PQ).
• Support audit readiness and documentation traceability.

🎓 Education & Experience Requirements

Required:

• Bachelor’s degree in Science or Engineering
• 4+ years of experience as a Validation Engineer in medical device, pharmaceutical, or similarly regulated industry
• In-depth understanding of:
• Validation lifecycle (IQ, OQ, PQ)
• ISO 13485 , FDA cGMP , and MDD requirements
• Strong verbal and written communication in English
• Proven ability to manage end-to-end validation documentation and execution

⭐ Preferred / Desirable Qualifications

• Experience with J&J validation methodology
• Knowledge of GD&T (Geometric Dimensioning & Tolerancing)
• Experience using Adaptiv for documentation management
• Six Sigma Green Belt or Black Belt certification
• Strong statistical analysis skills and engineering qualifications

🛠️ Key Competencies

• Detail-oriented and highly organized
• Excellent analytical and technical writing skills
• Strong project management and multitasking abilities
• Effective communicator across cross-functional teams
• Proactive, independent, and able to work under minimal supervision

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