The MSAT Process Validation / Technical Services Specialist is responsible for supporting all aspects of the process lifecycle—including process understanding, design, qualification, commercial manufacturing support, and continuous monitoring and improvement. This role operates within a GMP-regulated manufacturing environment and collaborates across departments to ensure compliant, efficient, and robust manufacturing processes.
MAIN RESPONSIBILITIES
Process Lifecycle Management
Support activities relating to process understanding and process design
Develop and execute Process Performance Qualification (PPQ) protocols
Author PPQ reports and related documentation
Support commercial manufacturing operations
Drive process monitoring, trending, and continuous improvement initiatives
Process Qualification & Validation Activities
Lead cleaning validation and maintenance activities
Perform chemical and microbial hold studies
Verify vessel integrity
Assess polymeric contact materials
Support shipping validation and container closure integrity studies
Carry out resin and membrane lifecycle studies
Manage thermal validation and revalidation activities
(The scope of qualification activities is not limited to the above and may expand as required.)
Documentation & Systems
Utilize site systems including eLIMS, SAP, TruVault, Comet, Minitab, and Ellab
Ensure accurate documentation and data management in accordance with cGxP requirements
EDUCATION/QUALIFICATIONS
Experience in process validation and technical services within a GMP-regulated manufacturing environment
Strong understanding of process lifecycle management, process validation, and qualification methodologies
Proficiency with relevant site systems and data analysis tools
Excellent documentation skills aligned with cGxP standards
Ability to work collaboratively in cross-functional teams
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