Validation Engineer

Validation Engineer

Apex Systems is seeking a Validation Engineer to join our client, a global leader in the medical device industry. This position is located in Athens, GA and will also have some occasional travel to the Cornelia, GA area. This is starting as a 6 month contract, with high likelihood to extend or convert after that duration.

Requirements:

• 5+ years of experience in Lab Environment
• Knowledge of quality assurance systems (QMS)
• Knowledge of validation of technical systems and processes
• Knowledge of statistics and quality improvement techniques
• Has an advanced broad and in-depth knowledge/familiarity with laboratory testing and automation.
• High level of accuracy and experience in writing protocols/reports.
• Planning skills, ability to prioritize multiple commitments, and technical problem-solving ability
• A proactive personality who works independently and acts when needed.

Responsibilities:

• Ensures that systems within the Quality system are adequately validated.
• Contributes to the making of high-quality products by developing and improving laboratory testing.
• Handling complex quality assurance issues. Uses results, judgment, and initiative to improve processes and standards.
• Evaluates compliance with applicable laboratory standards and procedures.
• Act as a Validation Subject Matter Expert (SME) during projects, regulatory, MD, and notified body audits/inspections.
• Specifies and improves test method validations including writing protocols and reports.
• Writes and develops IQ/OQ/PQ/ CSV protocols and reports for new and existing laboratory equipment.
• Acts as an approver for Test methods, laboratory equipment validation, and other validations.
• Acts as a project leader for laboratory validation projects.
• Participates, when necessary, in projects involving other departments and activities.
• Makes recommendations on improving quality, efficiency, cost of company product(s), processes, and/or productivity techniques.
• Supports day-to-day laboratory troubleshooting for test equipment and unexpected test results.
• Gathers and analyses validation test result data.