CQV Engineer: GMP Commissioning, Qualification & Validation

ProQuality Network; Indianapolis (IN); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

ProQuality Network is seeking an experienced CQV Engineer to lead commissioning, qualification, and validation of facilities, utilities, systems, equipment, and processes within a GMP-regulated pharmaceutical environment.

The role collaborates with Engineering, Manufacturing, Quality Assurance, Automation, and external vendors to ensure proper commissioning, qualification, documentation, and ongoing compliance.

Qualifikationen

• Bachelor's degree in Engineering or related technical field.
• 3+ years in commissioning, qualification, validation in regulated manufacturing.
• Experience with GMP-regulated facilities, systems, and equipment.

Aufgaben

• Develop and execute CQV activities for facilities, utilities, systems, and equipment.
• Create qualification documentation: URS, FS, risk assessments, DQ, FAT/SAT, IQ, OQ, PQ.
• Develop and execute CQV protocols and reports.
• Support startup, commissioning, troubleshooting, and turnover activities.
• Review drawings, specs, manuals, P&IDs, and vendor docs.
• Ensure CQV activities link to critical quality attributes and process parameters.

Kenntnisse

CQV

GMP knowledge

Technical writing

Independent work

Ausbildung

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ

FAT/SAT

Jobbeschreibung

ProQuality Network is seeking an experienced CQV Engineer to lead commissioning, qualification, and validation of facilities, utilities, systems, equipment, and processes within a GMP-regulated pharmaceutical environment.

The role collaborates with Engineering, Manufacturing, Quality Assurance, Automation, and external vendors to ensure proper commissioning, qualification, documentation, and ongoing compliance.