Project Manager Quality Control/Validation Ireland / North Europe / Full-Time
About CAI: CAI is a 100% employee-owned 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.
Our Approach: Our approach is simple: we put the clients interests first, we do not stop until it is right, and we will do whatever it takes to get there.
Foundational Principles: 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 persons success is everyones success.
Team Before Self: 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.
Cutting-Edge Technologies: 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 seeking an experienced project manager with expertise in quality control and validation to join our expanding operations in Ireland.
This role is ideal for individuals with at least 8 years of relevant experience in project management, validation, or quality control within pharmaceutical, biotech, or life sciences industries.
Key Responsibilities:
* Lead and coordinate quality control and validation 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 quality control 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.
Position Requirements: - Bachelors or masters 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.
- 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 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 quality and project management, we encourage you to apply.