More jobs:
Sr. Commissioning, Qualification & Validation "CQV Engineer
Job in
Orlando, Orange County, Florida, 32885, USA
Listed on 2026-07-08
Listing for:
Techever Ventures
Full Time
position Listed on 2026-07-08
Job specializations:
-
Engineering
Pharma Engineer, Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Work Authorization
Only Green Card Holders.
We are actively seeking an experienced Sr. Commissioning, Qualification & Validation (CQV) Engineer to support pharmaceutical manufacturing projects. If you have a strong background in equipment, utilities, facilities qualification, and GMP validation, we'd love to connect!
Key Responsibilities- Lead and execute Commissioning & Qualification (C&Q) activities for equipment, facilities, and utilities.
- Develop, review, approve, and execute Commissioning Protocols, IQ, OQ, and PQ documentation.
- Coordinate qualification activities across cross-functional teams.
- Support commissioning and qualification projects from planning through execution.
- Maintain the validated state of GMP systems and assess change impacts.
- Manage qualification data with integrity to support GMP decisions.
- Investigate deviations, troubleshoot qualification failures, and implement corrective actions.
- Drive continuous improvement of validation programs and C&Q best practices.
- Support regulatory inspections and present validation documentation when required.
- Bachelor's degree with 5+ years of relevant experience, or Master's degree with 3+ years experience.
- Strong knowledge of 21 CFR Part 11, 21 CFR 211, and 21 CFR 820
. - Familiarity with ISPE Guidelines and applicable ISO Standards
. - Hands‑on experience with qualification/validation of:
- Pharmaceutical manufacturing equipment
- Utilities
- Facilities
- Process validation
- Computerized systems (CSV)
- Sterile, inhalation, or medical device manufacturing environments
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