Biotech and Pharmaceutical, Calibration, Change Control, Commissioning - Engineering, Cross-Functional, Data Quality, Documentation, Equipment Maintenance/Repair, Event Management, GMP (Good Manufacturing Practices), Laboratory Equipment, Maintain Compliance, Manufacturing, Process Validation, Protocol Analysis, Quality Assurance, Quality Control, Regulatory Compliance, Risk Analysis, System Validation, Traceability, Validation Documentation
Hello,
I hope you're doing well.
My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Principal Commissioning & Validation Engineer based in Boston, MA with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com
Job Title: Principal Commissioning & Validation Engineer
Location: Boston, MA
Job Summary:
The Principal Commissioning & Validation Engineer will lead validation activities to ensure GMP compliance across manufacturing, laboratory equipment, and computerized systems.
This role supports QMS processes, validation documentation, and cross-functional collaboration to maintain a robust validation program.
Key Responsibilities:
- Maintain validation programs in compliance with GMP regulations
- Review and approve validation (QAV) documentation for internal and CMO operations
- Manage QMS events including Change Controls, CAPAs, and Deviations
- Support computerized systems, data integrity, and periodic reviews
- Lead validation deliverables such as protocols, risk assessments, and URS
- Act as SME for equipment calibration, maintenance, and lifecycle management
- Oversee equipment qualification, requalification, and decommissioning
- Collaborate with QA, QC, and Manufacturing teams to ensure compliance
Requirements:
- Bachelor's degree in Engineering or related field
- 10+ years of QA/Validation experience in the pharmaceutical industry
- Strong knowledge of GMP, QMS processes, and validation documentation
- Experience with computerized systems and validation activities
Preferred Qualifications:
- Expertise in drafting/reviewing validation documents
- Familiarity with risk assessments, configuration specs, and traceability matrices
Thanks & Regards,
Vyshnavi
Recruiter
Intellectt Inc
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225