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Quality Assurance Engineer

2 months ago

College Station, Texas, United States Valspec Full time
Job Overview

Valspec, a leading provider of system validation and lifecycle services, specializes in the commissioning and qualification of computerized systems within the Life Sciences sector. Our commitment since 1999 has been to deliver a comprehensive range of services that empower our clients to achieve their capital project and lifecycle maintenance objectives.

The projects we undertake are vital to the industry and the individuals who depend on our solutions. Many of our initiatives facilitate the availability of transformative medications; others enhance production efficiency to meet market demands while fostering the development of innovative therapies.

Position: Validation Engineer – EDMS

Location: Texas

Role Summary:

We are in search of a proficient and seasoned Validation Engineer to contribute to our projects on a full-time basis. The selected candidate will play a crucial role in the qualification of the Meridian Engineering Documentation Management System (EDMS), essential for managing CAD drawings and associated documentation.

Key Responsibilities:
  • Conduct Computer System Validation (CSV) of the Meridian EDMS, ensuring adherence to applicable standards and regulations.
  • Leverage expertise in Meridian/Bluecielo systems to pinpoint potential gaps and reinforce validation methodologies.
  • Supervise the CSV of the configuration, rigorously assessing the testing scope to ensure thorough coverage.
  • Formulate and implement a comprehensive migration strategy for the integration of drawings and documents into the Meridian system.
  • Validate the IOQ Infrastructure (Cache server) and the Vault (Test scripts) as integral components of the system's framework.
  • Work collaboratively with the software development team, noting that 60% of the Meridian software is custom developed.
Qualifications:
  • Demonstrated experience as a CSV Engineer, ideally with practical knowledge of Meridian/Bluecielo systems.
  • Solid understanding of engineering DMS, particularly those that oversee CAD drawings.
  • Willingness to work on-site, as the project necessitates a physical presence for paper-based validation.
Preferred Skills:
  • Candidates with a robust background in DI and experience in IOQ Infrastructure will be prioritized.

If you are a meticulous and dedicated Validation Engineer with a commitment to maintaining the integrity of engineering documentation systems, we invite you to consider this opportunity.

Valspec is proud to offer a distinctive culture, an excellent work environment, and competitive benefits, including premium medical coverage, 401K matching, profit sharing, tuition reimbursement, and other unique incentives.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status, or any other protected class. We are dedicated to fostering a professional environment free from discrimination or harassment and are proud to maintain a Drug-Free Workplace.