Pharma CQV Lead - Large-Scale Facility Retrofit

Morgan McKinley; Athlone; On-site; EUR 120,000 - 180,000; Full time

Job summary

Morgan McKinley is seeking a Senior Commissioning & Qualification Manager to lead CQV activities for a major OSD pharmaceutical retrofit. You will oversee strategy, schedule, quality, safety and compliance during CQV, coordinating client-side teams and external partners across HVAC, cleanrooms, utilities and process equipment.

Ideal candidates have 12+ years in pharma commissioning, strong management of commissioning partners, and proven ability to deliver complex CQV programs in regulated

Qualifications

• Degree qualification in Engineering, Science, related discipline or relevant experience
• Relevant experience in pharmaceutical and GMP regulated manufacturing environments

Responsibilities

• Develop and own CQV strategy and execution plan aligned to project schedule and GMP requirements up to PQ
• Lead system commissioning/qualification of HVAC, cleanrooms, utilities, equipment per schedule
• Coordinate CQV interfaces and manage commissioning partners and sub-contractors
• Coordinate internal client team including Work Package Owner and CQV resources
• Interface with Quality, Manufacturing, EHS, Engineering and QC
• Provide CQV status reporting to Senior Project Manager and governance forums
• Drive risk management and maintain risk registers
• Oversee turnover activities and ensure system handover to CQV and Operations

Skills

Project management

Stakeholder management

CQV leadership

GMP knowledge

Regulatory awareness

Risk management

Education

Engineering degree

Science degree

Tools

CSV fundamentals

Job description

Morgan McKinley is seeking a Senior Commissioning & Qualification Manager to lead CQV activities for a major OSD pharmaceutical retrofit. You will oversee strategy, schedule, quality, safety and compliance during CQV, coordinating client-side teams and external partners across HVAC, cleanrooms, utilities and process equipment.

Ideal candidates have 12+ years in pharma commissioning, strong management of commissioning partners, and proven ability to deliver complex CQV programs in regulated