Specialization · GAMP 5
Validation (CSV)
Computer Systems Validation, equipment qualification, and IQ/OQ/PQ leadership for GxP environments.
Core Capabilities
What our placed engineers do daily.
- GAMP 5 lifecycle authorship — URS, FRS, DS, IQ, OQ, PQ
- 21 CFR Part 11 compliance assessments and remediation
- Equipment qualification: autoclaves, lyophilizers, isolators, HVAC
- Empower 3, LIMS, MES, and SCADA validation
- Periodic review, change control, and validation master plans
- Data integrity (ALCOA+) audits and gap remediation
FAQ
Frequently Asked Questions
We place CSV (Computer System Validation) Engineers, Process Validation Scientists, Equipment Qualification Specialists (IQ/OQ/PQ), Cleaning Validation Engineers, and Method Validation Analysts across pharma and biotech sites in the NY/NJ corridor.

