Validation Engineer
Job Overview
Job Title: Validation Engineer
Location: Norwood, MA
Employment Type: Contract
About US
DMV IT Service LLC, founded in 2020, is a trusted IT consulting firm specializing in IT infrastructure optimization, cybersecurity, networking, and staffing solutions. We partner with clients to achieve technology goals through expert guidance, workforce support, and innovative solutions. With a client-focused approach, we also provide online training and job placements, ensuring long-term IT success.
Job Purpose
We are seeking an experienced and motivated Senior Validation Engineer to support digital and process optimization initiatives within a regulated laboratory environment. This position focuses on enhancing system efficiency, improving data integrity, and integrating advanced analytical technologies. The role requires close collaboration with technical and operational teams to ensure that digital systems meet validation, compliance, and performance standards.
Requirements
Key Responsibilities
- Partner with cross-functional teams to perform Data Integrity Risk Assessments (DIRA), identifying system risks and closing validation gaps.
- Develop a streamlined workflow for sample management and data reporting by integrating electronic data systems and leveraging automated reporting capabilities.
- Author Risk Assessments and User Test Cases to validate analytical instruments and data platforms.
- Lead validation activities for high-resolution analytical and sequencing technologies to ensure data integrity and compliance.
- Oversee data storage, migration, and transfer solutions within secure cloud environments to support large scientific datasets.
- Apply Computer Systems Validation (CSV) principles and maintain lifecycle documentation in alignment with GLP/GCLP/GMP regulations.
- Contribute to continuous improvement, change control, and deviation management processes.
- Provide technical expertise on validation strategies and system performance enhancements.
Required Skills & Experience
- Education: Master’s degree in Engineering, Life Sciences, or a related technical discipline, or equivalent relevant experience.
- Experience: 5–8 years in a regulated Pharmaceutical or Biotechnology environment (GLP/GCLP/GMP).
- Strong proficiency in Computer Systems Validation (CSV) and equipment lifecycle management.
- In-depth expertise in Watson LIMS or similar Laboratory Information Management Systems.
- Comprehensive understanding of data integrity principles and digital compliance requirements.
- Hands-on experience with Kneat, Veeva, and ServiceNow platforms.
- Proven ability to manage Change Control, Continuous Improvement, and Deviation processes.
Preferred Qualifications
- Excellent written and verbal communication skills.
- Demonstrated ability to work both independently and collaboratively within cross-functional teams.
- Strong analytical and problem-solving mindset.
- Self-driven with a commitment to maintaining high standards of compliance and technical excellence.
- Enthusiastic about contributing to an organization that values innovation, collaboration, and continuous learning.