Project Manager – CQV Engineer
Miejsce pracy: Dublin
Your responsibilities
* 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 commissioning, qualification, and validation, 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.
Our requirements
* Bachelor's or master's degree in engineering, life sciences, or a related field.
* 8+ years of experience in project management, quality control, or validation within the pharmaceutical, biotech, or life sciences industries.
* Experience with regulatory compliance standards (GMP, FDA, EU Annex 15, ISO) and industry best practices.
* Project Management certification is desirable for example – PMP certification.
* 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.
* Must have advanced English skills at comparable to C1 Cambridge level
* Must be willing and able to relocate to Ireland.
What we offer
Why CAI?
At CAI, we foster an environment of professional growth, collaboration, and hands-on learning. As CAI is a consulting 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
Are You Ready – For an exciting new career?
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
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 culture, we invest in YOUR future through hands-on certifications and professional training.
Position Overview:
We are looking for an experienced CQV Engineer / Project Manager to join our team and relocate to Ireland. This role is ideal for individuals with at least 8 years of relevant experience in project management, validation, or quality control within the pharmaceutical, biotech, or life sciences industries.
The project manager will play a crucial role in overseeing commissioning, qualification, and validation (CQV) projects, ensuring regulatory compliance, coordinating project activities, and maintaining efficient timelines. Due to the international scope of projects, willingness and ability to relocate and travel within Europe are essential.
Relocation Support
At CAI, we offer a comprehensive relocation package to ensure a smooth transition to your new country. This includes financial assistance, temporary accommodation, and travel support. Our team will guide you every step of the way to make your move as seamless as possible
Commissioning Agents (CAI)
Cześć Are you a skilled CQV Engineer with Project Management experience based in Poland and looking for an exciting opportunity to relocate? We are seeking experienced professionals ready to take the next step in their careers by moving to Ireland to work on cutting-edge biopharmaceutical projects.
CAI is a CAI is a consulting company established in 1996, growing year over year to nearly 700 employees worldwide. We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness in FDA-regulated and other mission-critical industries.