Senior CQV & Validation Engineer, Pharma/Biotech

MMR Consulting

Greenville (SC)

On-site

USD 95,000 - 140,000

Full time

2 days ago

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Job summary

MMR Consulting, an engineering and consulting firm focused on pharmaceutical and biotechnology industries, seeks a seasoned professional to lead commissioning, qualification and validation efforts. The role involves work on client sites in Augusta, GA and other locations, coordinating cross-functional teams and delivering GMP-compliant validation projects.

The candidate should bring 5+ years in pharma/biotech validation, familiarity with cGMP, and experience with DQ/IQ/OQ/PQ and related

Qualifications

5+ years in commissioning, qualification or validation in pharma/biotech.
Experience with cGMP operations in pharma/biotech.
Experience with commissioning & qualification of equipment & facilities.
Knowledge of validation approaches (Risk-Based, ASTM E-2500 or ISPE ICQ) is a plus.
Leadership or mentorship experience is an asset.

Responsibilities

Provide technical guidance in the commissioning, qualification and start-up of GMP process equipment.
Lead development of qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ.
Perform field execution of qualification test cases and protocols.
Support development of Project Validation Plans (PVPs).
Lead qualification processes to meet quality and engineering specifications.
Coordinate meetings with cross-functional departments to drive project progress.
Travel may be occasionally required for meetings with vendors or FATs.