MSAT Validation SME
Listed on 2026-09-20
-
Engineering
Validation Engineer, Quality Engineering, Pharma Engineer -
Pharmaceutical
Validation Engineer, Quality Engineering, Pharma Engineer, Pharmaceutical Manufacturing
MSAT Validation SME
Location: Greenville, NC
Duration: 12 Months
Job Type: Contract
Job Overview:
Our pharmaceutical client is seeking an experienced MSAT & Validation SME to support a major new site expansion project in Greenville, NC. The ideal candidate will have a strong background in Manufacturing Science & Technology (MSAT), process validation, technology transfer, CSV, and project management
.
The consultant will support the implementation and validation of new manufacturing processes and electronic batch record systems as the new facility comes online.
Key Responsibilities:- Support MSAT activities associated with the new site expansion and facility launch.
- Lead/support technology transfer and process implementation activities.
- Support process validation and continuous improvement initiatives.
- Assist with implementation, validation, and management of Electronic Batch Record (E ) systems.
- Support Computer System Validation (CSV) activities, including:
- URS
- FRS
- IQ
- OQ
- PQ
- Develop and participate in risk assessments and validation documentation.
- Help manage and coordinate projects across multiple onsite teams.
- Facilitate project meetings and drive action items to completion.
- Collaborate closely with MSAT, Engineering, Quality, IT, Manufacturing, Validation, and other cross-functional teams
. - Ensure processes and systems are properly established and ready for successful site launch.
- Provide strong technical and project leadership throughout the expansion.
- MSAT / Manufacturing Science & Technology
- Computer System Validation (CSV)
- Process Validation
- Technology Transfer
- Project Management
- Electronic Batch Records / E
- URS, FRS, IQ, OQ, PQ
- Risk Assessments
- Strong communication and cross-functional collaboration skills
- Pharmaceutical / GMP manufacturing experience
The ideal candidate will be a hands-on MSAT and Validation SME with strong pharmaceutical manufacturing experience who can bridge process, validation, technology, and project management activities during a new facility expansion.
#MSAT #Validation #CSV #Pharma Jobs #Pharmaceutical #Process Validation #Technology Transfer #E #GMP #Project Management #North Carolina #Contract Job
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