Technical Source is currently in search of a highly organized and detail-oriented PQ Validation Engineer for our client located in the Raleigh-Durham, NC area.

This role will be responsible for working cross-functionally with the CQV team and Process Science to commission, qualify, and validate downstream systems and ensure full alignment of CPPs and CQAs. 

Responsibilities of the PQ Validation Engineer include:

• Support generation of CQV Downstream documentation (FAT, DQ, RTM, QRA, SAT, IOQ, Summary Reports) 
• Generate Downstream bridging documentation, ensuring alignment with Process Science regarding Critical Process Parameters and Critical Quality Attributes 
• Execution of PQ activities for Downstream Systems, In process sampling, microbial hold studies, and mixing qualification 
  

Qualifications of the PQ Validation Engineer include:

• 5 years experience working within the Full CQV Validation life cycle
• Experience in the execution of Downstream PQ activities including documentation generation/summary reports, in process sampling, and microbial hold studies 
• Strong time management, communication and problem-solving skills

Key Words: CQV, Commissioning, Qualification, Clean Steam generation systems, Water generation systems, Process Gas systems, IV,OV,IQ,OQ,PQ, Validation, Equipment, Clean Utilities, Autoclaves, Temperature mapping, CTU, PQ, downstream PPQ, Process Validation, microbial hold studies