More jobs:
Validation Specialist
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-05-31
Listing for:
United Pharma Technologies Inc
Full Time
position Listed on 2026-05-31
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Job Title:
Senior Validation Engineer (IVD / Medical Devices)
We are looking for a Senior Validation Engineer to lead validation activities for manufacturing processes, equipment, test methods, and computerized systems in a regulated IVD / Medical Device environment. This role ensures compliance with global regulatory standards and supports both new and legacy process validation.
Key Responsibilities- Execute and lead IQ/OQ/PQ, Test Method Validation (TMV), and CSV (GAMP
5) - Develop validation plans, protocols, and reports
- Perform risk-based validation (ISO 14971), CTQ alignment, and statistical analysis (MSA)
- Support change control, deviation investigations, and revalidation activities
- Ensure compliance with ISO 13485, IVDR (EU 2017/746), FDA 21 CFR 820/11
- Collaborate with QA, Manufacturing, R&D, QC, and IT teams
- Support NPI, process transfers, and continuous improvement initiatives
- Bachelor’s or Master’s in Engineering or related field
- 10+ years of validation experience in Medical Devices / IVD / Pharma
- Strong hands‑on experience in IQ/OQ/PQ, TMV, and CSV
- Validation lifecycle (process, equipment, methods, systems)
- Statistical tools (MSA, capability analysis)
- Strong technical writing and documentation skills
- Experience in GxP and regulatory environments
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:
×