Hello,
I Hope you are doing great.
This is Mahaboob from Intellectt INC; We have an urgent opening for a Validation Engineer position based in New York with one of our prestigious clients.
If you are interested or know someone who might be a good fit, please share your updated resume at mahaboob.m@intellectt.com.
Job Title: Validation Engineer
Location: New York
Summary:
Seeking a Validation Engineer with strong experience in analytical instruments and CSA/CSV to support GMP operations in biologics / cell & gene therapy environments.
Key Responsibilities:
- Execute IQ/OQ/PQ for HPLC, GC, LC-MS, UV, dissolution systems
- Perform CSA/CSV for lab systems (LIMS, Empower, Chromeleon)
- Develop validation docs: URS, risk assessments, protocols, reports
- Ensure compliance with 21 CFR Part 11, GAMP 5, Data Integrity (ALCOA+)
- Support method validation, change control, and audits
Requirements:
- 4–6+ years in GMP validation (pharma/biotech)
- Hands-on with analytical instruments + CSA/CSV
- Experience in biologics / cell & gene therapy preferred
Thanks & Regards,
Mahaboob M
Technical Recruiter
Intellectt Inc
mahaboob.m@intellectt.com
Direct: 732-276-1830
Desk number: 732 412 6999- Ext: 355