Lead CQV Validation Engineer — Pharmaceutical

MMR CONSULTING; Greenville (SC); On-site; USD 90,000 - 120,000; Full time

Job summary

MMR Consulting in Augusta, GA seeks a senior Validation Engineer to lead commissioning, qualification and start-up of cGMP process equipment, utilities and facilities. You will guide field execution, coordinate cross-functional teams, and ensure adherence to regulatory and client requirements.

You will develop and review DQ, FAT, IQ, OQ and PQ deliverables, mentor junior staff, and support project validation plans.

Qualifications

• 5+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Experience with commissioning & qualification of equipment & facilities.
• Background in cGMP operations.
• Experience with Risk-Based Commissioning & Qualification approaches (e.g., ASTM E-2500 or ISPE ICQ).
• Leadership and mentorship experience preferred.
• Engineering degree in Mechanical, Electrical or Chemical.
• Willingness to travel occasionally.

Responsibilities

• Provide technical guidance in the commissioning, qualification and start-up of various pharmaceutical/biopharmaceutical cGMP process equipment, utilities & facilities.
• Lead the development of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.
• Able to perform field execution of qualification test cases and protocols.
• Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
• Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following – Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…), Downstream Bioprocess Equipment (Chromatography, TFF, etc..), Process equipment.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, into design reviews and decisions.
• Travel may be occasionally required for meetings with equipment fabrication vendors or FATs.
• Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases.
• Visit construction and installation sites, wearing necessary safety PPE.
• Lead/Mentor a team of validation engineers/specialists.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Skills

Validation leadership

Project management

cGMP knowledge

Process validation

Team mentoring

Cross-functional coordination

Regulatory compliance

Education

Engineering degree

Tools

PCS/SCADA systems

DCS/PLC control systems

IQ/OQ/PQ tools

Job description

MMR Consulting in Augusta, GA seeks a senior Validation Engineer to lead commissioning, qualification and start-up of cGMP process equipment, utilities and facilities. You will guide field execution, coordinate cross-functional teams, and ensure adherence to regulatory and client requirements.

You will develop and review DQ, FAT, IQ, OQ and PQ deliverables, mentor junior staff, and support project validation plans.