More jobs:
Sr. Validation Engineer
Job in
Indianapolis, Marion County, Indiana, 46262, USA
Listed on 2025-11-29
Listing for:
Harba Solutions Inc.
Full Time
position Listed on 2025-11-29
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Job Responsibilities:
- Lead equipment, facility, utility, and process validation activities (IQ/OQ/PQ)
- Author, review, and execute validation protocols and summary reports
- Ensure compliance with FDA, EMA, and cGMP regulations
- Collaborate cross-functionally with Quality, Manufacturing, and Engineering teams
- Drive continuous improvement in validation strategies and risk-based approaches
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 4+ years of validation experience in a CDMO, pharma, or biotech environment
- Strong knowledge of GMP validation requirements and risk-based validation (e.g., ASTM E2500)
- Experience with cleanroom validation, autoclaves, SIP/CIP, and process equipment
- Excellent technical writing and communication skills
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×