Validation Engineer - Electrical Design Drawings (Remote)

About the Role

We are seeking a skilled Validation Engineer - Electrical Design Drawings (Remote) to join our dynamic team at VTekis Consulting LLP. In this role, you will leverage your expertise in validation activities, particularly within the realms of medical devices and life sciences, to ensure compliance and quality throughout the project lifecycle.

What You'll Do

• Provide validation experience and guidance during equipment design, software design, build, debug, and qualification phases of a project.
• Write overall project quality (validation scope) plans to ensure all aspects of the project meet regulatory requirements.
• Organize, guide, and write requirement specifications as necessary to maintain clarity and compliance.
• Review qualification/requalification packages for completeness and accuracy, ensuring sound rationale and adherence to validation policies.
• Interface with internal and client validation and engineering teams to secure document approvals efficiently.
• Oversee and execute validation qualifications at our facility and at the customer’s site, ensuring all processes are documented and compliant.
• Create validation summary reports and provide input to address validation deviations and/or change requests.
• Drive a quality approach into the organization, focusing on change control and documentation for equipment design, software, and documentation.

Requirements

• 3+ years of experience performing validation activities, particularly in medical devices or life sciences.
• Proficient in Microsoft Office and familiar with GAMP 5 based validation models.
• Experience working with electrical design drawings and Rockwell Automation PLC Control Systems is preferred.
• Excellent presentation skills and ability to mentor without direct authority.
• Self-starter with the ability to work with minimal guidance in a team environment.
• Experience debugging and working with custom machines is a plus.
• Strong organizational skills to manage multiple projects and deadlines effectively.
• Ability to develop pertinent document templates tailored to customer SOPs.

Nice to Have

• Experience in a regulated environment, particularly cGxP.
• Knowledge of validation lifecycle processes.
• Familiarity with industry standards and best practices in validation.

What We Offer

• Competitive salary range of $90,000 - $120,000 per year.
• Remote work flexibility, allowing you to work from anywhere.
• Opportunities for professional development and career growth.
• Supportive team environment with a focus on quality and compliance.
• Comprehensive benefits package including health insurance and paid time off.