Validation Engineer II
On-siteHouston, Texas, United States
Houston, Texas, United StatesOn-siteFull TimeHealthcare TechMedium
Full TimeMediumHealthcare Tech
Job Summary
Draft validation documents including plans, user requirements specifications, risk assessments, and IQ/OQ/PQ protocols. Execute test scripts using good documentation practices and create project timelines for deliverables. Monitor Quality Management Systems, including CAPAs, change controls, and deviations, while coordinating investigations and drafting SOPs. Support cross-functional groups for audits, training, and system requalifications throughout the lifecycle. Work on-site Monday through Friday from 8:00 AM to 5:00 PM.
Required Qualifications
- Bachelor's degree in Science, Engineering or a related major
- 5+ years experience in the pharmaceutical or biotech industry
- Work Authorization: Applicants must be authorized to work in the United States without the need for current or future sponsorship
- Employment is contingent upon successful completion of a background check, reference checks and pre-employment drug screening
Desired Qualifications
- Education in Biotechnology or a related major preferred
- Experience working within a GxP regulated manufacturing or laboratory environment
- An understanding of good documentation practices and data integrity principles
- Demonstrated understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, GAMP 5 and USP
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