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Senior Design Verification Lead
Job in
Lebanon, Boone County, Indiana, 46052, USA
Listed on 2026-06-10
Listing for:
Saxon Global
Full Time
position Listed on 2026-06-10
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering, Systems Engineer, Automation & Mechatronics Engineer
Job Description & How to Apply Below
- Develop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes.
- Ensure alignment with GMP
, ICH Q8-Q11
, FDA
, EMA
, and ISPE Baseline Guide expectations for biologics manufacturing. - Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments.
- Serve as a Technical Lead an design verification authority for designated scopes in support of a new site facility build out
. Design Verification Program Leadership - Develop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes.
- Ensure alignment with GMP
, ICH Q8-Q11
, FDA
, EMA
, and ISPE Baseline Guide expectations for biologics manufacturing. - Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments.
- Serve as a Technical Lead an design verification authority for designated scopes in support of a new site facility build out
Position Requirements
10+ Years
work experience
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