Senior CQV Engineer - GMP Validation & Process Optimization

Staftonic LLC; Kentucky; On-site; USD 90,000 - 150,000; Full time

Job summary

Staftonic LLC is seeking a CQV Lead to drive commissioning, qualification, and validation activities in a GMP manufacturing environment. The role involves hands-on work with packaging processes, protocol execution, and real-time troubleshooting on the floor.

You will develop IQ/OQ/PQ documents, apply Minitab for process characterization, and perform advanced statistical analyses. Strong writing and cross-functional collaboration are essential for successful commercialisation.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related technical discipline.
• Experience in CQV, validation, process engineering in GMP/pharma/medical devices.
• Hands-on with packaging equipment and automated manufacturing.
• Proficient in Minitab and statistical methods.

Responsibilities

• Lead CQV activities in a GMP manufacturing environment.
• Develop and execute qualification/validation protocols (IQ/OQ/PQ).
• Author validation plans, protocols, and reports.
• Perform statistical analysis to support process validation and capability studies.
• Lead deviation investigations, root-cause analysis, and CAPA activities.
• Collaborate with Quality, Manufacturing, Engineering, and R&D to support commercialisation.

Skills

CQV

Validation

Process engineering

Minitab

DOE

Cp/Cpk

MSA/Gage R&R

GMP

Statistical analysis

Education

Bachelor's degree in engineering or life sciences

Tools

KNEAT

Veeva

TrackWise

Job description

Staftonic LLC is seeking a CQV Lead to drive commissioning, qualification, and validation activities in a GMP manufacturing environment. The role involves hands-on work with packaging processes, protocol execution, and real-time troubleshooting on the floor.

You will develop IQ/OQ/PQ documents, apply Minitab for process characterization, and perform advanced statistical analyses. Strong writing and cross-functional collaboration are essential for successful commercialisation.