Overview

PM Group is a leading international engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of over 4000+ people, we deliver complex capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.

Due to our ongoing success securing large-scale projects we now have a requirement for a CQV Lead Engineer based onsite with us in Tipperary.

Who Are We

PM Group is an employee owned, international project delivery firm. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners.

Responsibilities

Lead the planning, coordination and execution of Commissioning, Qualification and Validation (CQV) activities for API manufacturing facilities and associated utility systems.
Develop and implement CQV strategies, validation plans, schedules and resource requirements in alignment with project and client objectives.
Author, review and approve CQV documentation including:

Validation Master Plans (VMPs)
Risk Assessments
Traceability Matrices
Commissioning Test Scripts
IQ/OQ/PQ Protocols
Summary Reports

Provide CQV leadership during design reviews, constructability reviews, FATs, SATs and system turnover activities.
Coordinate cross-functional project teams including Engineering, Automation, Quality Assurance, Manufacturing, Operations and vendor partners.
Ensure commissioning and qualification activities are executed in compliance with GMP requirements, regulatory expectations and company procedures.
Manage deviation investigations, change controls and CAPA activities arising during CQV execution.
Drive issue resolution and support root cause investigations to ensure timely project delivery.
Support regulatory inspections, client audits and quality assessments through comprehensive documentation and SME support.
Mentor and guide junior CQV engineers while promoting best practices and a strong safety and quality culture.
Provide regular progress updates to PM Group project management and client leadership teams.

Qualifications

Bachelor's degree in Engineering, Pharmaceutical Science, Life Sciences or a related technical discipline.
Minimum 10 years' experience within Commissioning, Qualification and Validation in the pharmaceutical, biotechnology or life sciences sector.
Proven experience leading CQV teams on large-scale capital projects within API or bulk pharmaceutical manufacturing environments.
Strong understanding of GMP regulations and industry guidance including:
- FDA
- EMA
- ICH
- ISPE Baseline Guides
- GAMPS
- 21 CFR Part 11
- Annex 11
Demonstrated experience qualifying process equipment, clean utilities, facilities and automation systems.
Experience with DeltaV, PCS, SCADA or equivalent process control systems is highly desirable.
Strong stakeholder management skills with experience working in client-facing project environments.
Ability to manage multiple priorities within fast-paced project execution teams.
Excellent communication, leadership and problem-solving capabilities.

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are at the heart of our business strategy.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.

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CQV Lead – API

Job Description