CQV Lead

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

The CQV Lead is responsible for overseeing all Commissioning, Qualification, and Validation activities for assigned projects within the organization. The ideal candidate will have extensive experience in CQV processes within regulated (GMP) environments, excellent project leadership skills, and specific expertise with pharmaceutical or biopharmaceutical filling line projects is highly desirable.

Key Responsibilities:

• Lead, plan, coordinate, and execute CQV activities for assigned projects from initiation through completion.
• Develop and review CQV documentation, including User Requirements Specifications (URS), Qualification Protocols (DQ, IQ, OQ, PQ), and Traceability Matrices.
• Oversee and support commissioning and qualification of utilities, process equipment, facilities, and computerized systems.
• Ensure deliverables comply with applicable regulatory requirements (FDA, EMA, etc.) and internal quality standards.
• Manage cross-functional teams, coordinate with engineering, QA, production, and external vendors as required.
• Act as subject matter expert for CQV topics during regulatory inspections and internal/external audits.
• Report project status, issues, and risks to management, ensuring effective communication between stakeholders.
• Ensure timely completion of all CQV milestones, and manage any deviations or changes efficiently.
• Mentor and support junior CQV personnel on project teams.

Required Qualifications:

• Bachelor’s or higher degree in Engineering, Life Sciences, or related technical discipline.
• Minimum of 8 years of professional experience in CQV, commissioning, validation, or QA roles within the pharmaceutical, biotechnology, or related regulated industries.
• Proven track record delivering CQV projects in GMP manufacturing environments.
• Strong knowledge of regulatory standards and guidelines (e.g., cGMP, FDA, EU GMP, ICH Q8/Q9/Q10).
• Excellent project management, leadership, and communication skills.
• Demonstrated problem-solving skills and ability to work independently.

Preferred Qualifications:

• Direct experience with filling line projects (liquid and/or sterile filling equipment, packaging, automation, etc.).
• Experience with validation of automated systems, SCADA, DCS, or MES.
• Familiarity with risk management principles (e.g., FMEA, QRM).

Personal Attributes:

• Detail-oriented with an ability to see the bigger picture in project delivery.
• Strong organizational and prioritization abilities.
• Ability to thrive in a fast-paced, dynamic, and collaborative environment.