Validation Engineer
Intellectt INC
Hello,
I hope you're doing well.
My name is Purna , and I'm reaching out from Intellectt Inc . regarding an exciting opportunity for a Validation Engineer based in Winston-Salem, NC (Onsite) with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at View email address on us.fitly.work .
Title: Validation Engineer
Location : Winston-Salem, NC
Job Description
- Support equipment qualification and validation activities for medical device manufacturing equipment.
- Develop and execute validation protocols, including IQ, OQ, and PQ.
- Prepare validation plans, protocols, test scripts, and final validation reports.
- Perform validation testing and review results to ensure compliance with established acceptance criteria.
- Determine appropriate sample sizes for validation studies and support statistical evaluation of validation data.
- Work with Engineering, Quality, and Manufacturing teams to execute qualification and validation activities.
- Support investigation and resolution of validation-related issues, deviations, and documentation requirements.
- Ensure all validation activities comply with applicable FDA, GMP, quality, and company requirements.
Education & Experience
- Bachelor's degree in Engineering, Science, or a related technical field preferred.
- Strong experience in Validation Engineering, preferably within a medical device or other FDA-regulated manufacturing environment.
- Hands-on experience with equipment qualification, IQ/OQ/PQ, validation protocols, and sample size determination.
Skills
- Equipment Qualification
- Validation Engineering
- IQ / OQ / PQ
- Sample Size Determination
- Validation Protocols
- Medical Device Manufacturing
- FDA / GMP Compliance
- Validation Documentation
Thanks & Regards,
Purnasree.U
Recruiter
Intellectt Inc
View email address on us.fitly.work
Desk number: View phone number on us.fitly.work
Vacancy posted 1 day ago
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