Senior CQV Lead - GMP Validation & Commissioning Expert

EFOR; Cork; On-site; EUR 90,000 - 130,000; Full time

Job summary

EFOR is seeking a CQV Lead to oversee all commissioning, qualification, and validation activities across assigned pharma projects. The role requires extensive CQV experience in GMP environments and strong project leadership for filling line or related equipment projects.

You will develop URS, IQ/OQ/PQ/DQ, trace matrices, manage cross-functional teams, mentor junior staff, and ensure regulatory compliance with FDA/EU GMP guidelines.

Qualifications

• 8+ years in CQV, commissioning, validation, or QA in pharmaceutical/biotech GMP environments.
• Proven track record delivering CQV projects in GMP manufacturing.
• Knowledge of cGMP, FDA, EU GMP, ICH Q8/Q9/Q10.
• Strong project management, leadership, and communication skills.
• Ability to work independently.

Responsibilities

• Lead and execute CQV activities from initiation to completion.
• Develop and review URS, IQ, OQ, PQ, DQ, and trace matrices.
• Oversee commissioning/qualification of utilities, equipment, facilities, and computerized systems.
• Ensure compliance with FDA, EMA, and internal quality standards.
• Coordinate cross-functional teams with engineering, QA, production, vendors.
• Act as SME for CQV during regulatory inspections and audits.
• Report status, issues, and risks to management.
• Ensure timely completion of CQV milestones and manage changes.
• Mentor junior CQV personnel.

Skills

CQV Leadership

Project Management

Regulatory Knowledge

Excellent Communication

GMP Experience

Education

Bachelor’s or higher degree

Tools

SCADA

DCS

MES

Job description

EFOR is seeking a CQV Lead to oversee all commissioning, qualification, and validation activities across assigned pharma projects. The role requires extensive CQV experience in GMP environments and strong project leadership for filling line or related equipment projects.

You will develop URS, IQ/OQ/PQ/DQ, trace matrices, manage cross-functional teams, mentor junior staff, and ensure regulatory compliance with FDA/EU GMP guidelines.