Advantage Technical · 4 hours ago
Validation Engineer
Austin, Texas Metropolitan Area
Full-time
Onsite
Senior Level
5+ years expAdvantage Technical is seeking a Process Validation Engineer to join their team in Austin, Texas. This role is responsible for equipment validation to ensure compliance with internal policies, procedures, and regulatory requirements for medical device manufacturing.
Staffing & Recruiting
Hiring Manager
Lisa Burns
Responsibilities
Define qualification requirements and lead equipment and process validation activities to completion
Provide oversight for equipment qualification (IQ, OQ, TMV, PQ) and ensure compliance with regulatory and internal standards
Author, execute, and/or review validation plans, protocols, reports, risk assessments, traceability matrices, and change control documentation
Monitor validation activities to ensure adherence to approved procedures and maintain complete, accurate documentation
Collaborate with cross‑functional teams and customers on technical, quality, and continuous improvement initiatives
Make informed, independent decisions regarding validation approaches and technical issues
Evaluate alternative methods and propose solutions to meet operational and compliance needs
Support facilities validation and quality engineering projects as required by business needs
Qualification
Required
Bachelor's degree in Engineering, Science, or a related field, with 5–6 years of experience in the medical device, pharmaceutical, or biotechnology industries
Strong working knowledge of applicable regulatory and quality standards, including CFR Part 820, Part 11, ISO 13485, ISO 9001, Annex 11, and GAMP
Proven hands-on experience with manufacturing equipment validation, including developing and executing IQ/OQ/PQ/TMV and performing statistical analysis
Demonstrated ability to generate, review, and approve validation documentation such as protocols, reports, risk assessments, and change control records
Ability to work independently, manage multiple priorities, and make sound technical decisions with minimal supervision
Strong communication, organization, and problem‑solving skills
Preferred
Experience with Facilities validation working in a 24/7 operations environment
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
H1B Sponsorship
Advantage Technical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)
Funding
Current Stage
Late StageCompany data provided by crunchbase