Process Validation Engineer

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.

• 
  
• 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
  

• 
  
• 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.)
  

• 
  
• Utilize site systems including eLIMS, SAP, TruVault, Comet, Minitab, and Ellab
  
• Ensure accurate documentation and data management in accordance xcfaprz with cGxP requirements
  

• 
  
• 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