The Project Manager will lead CQV projects, ensuring compliance with regulations, managing documentation, and coordinating between clients and teams.
Project Manager – CQV Engineer
Ireland / North Europe / Full Time
About CAI:
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 employees worldwide. We provide commissioning, qualification, validation (CQV), start-up, project management, and consulting services related to operational readiness in FDA-regulated and other mission-critical industries.
Are You Ready?
Our approach is simple: we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
-We act with integrity,
-We serve each other,
-We serve society,
-We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI professionals are exposed to cutting-edge technologies in the advanced medicine space, working alongside recognized subject matter experts. As part of our company culture, we invest in YOUR future through hands-on certifications and professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a Project Manager with expertise in Quality Control and Validation to join our growing operations. In this CQV-focused role at CAI, the Project Manager will:
-Lead and coordinate CQV projects, ensuring timely execution and compliance with industry regulations.
-Oversee equipment qualification activities, including Design Evaluations, Factory Acceptance Testing (FAT), Installation -Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
-Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
-Act as the primary point of contact between clients, internal teams, and external vendors to drive project success.
-Manage documentation related to CQV, including Test Outlines and Procedures (TOPs), Qualification Summary Reports (QSRs), and change controls.
-Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
-Support continuous improvement initiatives by implementing best practices in project execution and quality assurance.
-Ensure that all stakeholders, including client teams, vendors, and subcontractors, adhere to established project protocols.
-Provide leadership in team meetings and facilitate problem-solving discussions to ensure project milestones are met.
-Ensure effective resource planning, including coordinating materials and consumables for commissioning and validation activities.
Position Requirements:
-BS or MS in engineering, life sciences, or a related field, or equivalent experience.
-8+ years of experience in CQV, project management, or quality control within pharmaceutical, biotech, or life sciences industries.
-Experience with regulatory compliance standards (GMP, FDA, EU Annex 15, ISO) and industry best practices.
-Strong leadership and communication skills, with the ability to manage multiple stakeholders and drive project success.
-Proven ability to develop and maintain project timelines, budgets, and risk assessments.
-Strong problem-solving skills, attention to detail, and a results-oriented mindset.
-Ability to work independently and as part of a cross-functional team.
-Fluent in English; additional European language skills are a plus.
-Must be willing and able to travel internationally based on project requirements.
Why CAI?
At CAI, we foster an environment of professional growth, collaboration, and hands-on learning. As an employee-owned company, you will be part of a team that values integrity, innovation, and long-term success. If you are a motivated professional with a passion for CQV and project management, we encourage you to apply.
Join us and shape the future of quality and validation in the life sciences industry!
Top Skills
Cqv
Eu Annex 15
Fda
Gmp
Iso
Project Management
Quality Control
Regulatory Compliance Standards
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