Quality Engineering & Validation Consultant
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-08-10
Listing for:
United Pharma
Full Time
position Listed on 2026-08-10
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
We are seeking an experienced Quality Engineering & Validation Consultant to provide GMP Quality oversight for manufacturing operations, validation activities, and capital projects in a biopharmaceutical environment. The ideal candidate will have strong experience supporting validation, investigations, CAPAs, and cross-functional quality initiatives.
Key Responsibilities:- Provide Quality oversight for GMP manufacturing, validation, and engineering projects.
- Review and approve change controls, validation protocols, investigations, CAPAs, and risk assessments.
- Support equipment, facility, utility qualification, calibration, and preventive maintenance activities.
- Collaborate with Manufacturing, Engineering, Validation, Facilities, and QA teams to ensure GMP compliance.
- Drive quality improvements, support inspection readiness, and identify compliance risks.
- Support environmental monitoring and facility control systems.
- BS in Engineering, Life Sciences, or a related field.
- 8+ years of QA experience in pharmaceutical, biotech, or cell & gene therapy manufacturing.
- Strong experience with GMP validation, investigations, CAPAs, change controls, and risk assessments.
- Knowledge of aseptic manufacturing and equipment/facility qualification.
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:
×