Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.
Validation Engineer – EDMS
Location: Texas
Job Description:
We are seeking a highly skilled and experienced Validation Engineer to join our team on a full-time basis for a minimum of 6+ months. The successful candidate will be responsible for the qualification of the Meridian Engineering Documentation Management System (EDMS), which is crucial for housing CAD drawings and related documents.
Key Responsibilities:
- Perform Computer System Validation (CSV) of the Meridian EDMS, ensuring compliance with relevant standards and regulations.
- Utilize expertise in Meridian/Bluecielo systems to identify potential gaps and ensure robust validation processes.
- Oversee the CSV of the configuration, challenging the testing scope to guarantee comprehensive coverage.
- Develop and execute a detailed migration plan for importing drawings and documents into the Meridian system.
- Validate the IOQ Infrastructure (Cache server) and the Vault (Test scripts) as part of the system's infrastructure.
- Collaborate closely with the software development team, as 60% of the Meridian software is custom coded.
Requirements:
- Proven experience as a CSV Engineer, preferably with hands-on experience with Meridian/Bluecielo systems.
- Strong understanding of engineering DMS, particularly those that manage CAD drawings.
- Ability to work on-site, as the project requires a physical presence for paper-based validation.
Preferences:
- Candidates with a strong background in DI and experience in IOQ Infrastructure will be given preference.
If you are a dedicated and meticulous Validation Engineer with a passion for ensuring the integrity of engineering documentation systems, we encourage you to apply for this exciting opportunity.Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.Any third-party unsolicited resume submission(s) will immediately become the property of Valspec.
Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.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 committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
