CQV/Validation Engineer

4 weeks ago

Limerick, Ireland CAI Full time

About CAI:

CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

Meeting a Higher Standard:

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:

1. We act with integrity,
2. We serve each other,
3. We serve society,
4. 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 agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as 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 CQV Engineer to join our growing operations in Ireland. The role of a CQV Engineer in CAI is to:

1. Conduct and lead Commissioning, Qualification, Validation team activities with a direct regard for Safety.
2. Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
3. Generate C&Q Procedures for projects.
4. Approve TOPs.
5. Facilitate scoping / planning of commissioning spares and consumables.
6. Deliver the C&Q activities as required to meet the schedule.
7. Track progress of C&Q activities as required.
8. Prepare Qualification Summary Reports (QSR), and manage Requirement Traceability Matrix (RTM).
9. Execute Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
10. Manage any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.
11. Coordinate with project contractors and equipment vendors to execute required tests.
12. Allocate project resources for efficient execution of project deliverables.
13. Coordinate support during C&Q execution.

Position Requirements:

1. BS or MS in a relevant science or engineering field, or equivalent.
2. 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable.
3. Excellent oral and written communication skills.
4. Excellent problem-solving skills.
5. Customer-service focused.
6. Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
7. Able to travel domestically and internationally if required.

We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties.

#J-18808-Ljbffr

  • CQV/Validation Engineer

    2 days ago

    Limerick, Limerick, Ireland CAI Full time

    About CAI:CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.Meeting a Higher Standard:Our...

  • CQV Engineer

    4 weeks ago

    Limerick, Ireland PM Group Full time

    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 3,600 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • CQV Engineer

    2 weeks ago

    Limerick, Limerick, Ireland PM Group Full time

    OverviewPM 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 3,600 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • CQV Engineer Downstream

    3 weeks ago

    Limerick, Limerick, Ireland PM Group Full time

    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 3,600 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • CQV Engineer Downstream

    2 weeks ago

    Limerick, Ireland PM Group Full time

    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 3,600 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • Cqv Engineer Downstream

    2 days ago

    Limerick, Limerick, Ireland Pm Group Full time

    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 3,600 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • Cqv Engineer

    3 hours ago

    Limerick, Limerick, Ireland Pm Group Full time

    OverviewPM 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 3,600 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and...

  • Senior CQV Specialist

    15 minutes ago

    Limerick, Limerick, Ireland Pm Group Full time

    About the RoleWe are seeking a highly experienced Senior CQV Engineer to join our team based onsite with a key client in Limerick. As a Senior CQV Engineer, you will be responsible for leading the commissioning and qualification of various equipment and systems within a Pharmaceutical facility.Key ResponsibilitiesField execution of Commissioning,...

  • CQV Operations Manager

    4 days ago

    Limerick, Limerick, Ireland CAI Full time

    About UsAt CAI, we're passionate about delivering exceptional results and exceeding our customers' expectations. With a strong commitment to safety, quality, and customer satisfaction, we provide commissioning, qualification, validation, start-up, project management, and consulting services to FDA-regulated industries.Our ValuesWe live by our Foundational...

  • CQV Operations Manager

    2 days ago

    Limerick, Limerick, Ireland CAI Full time

    About CAIWe are a global company with nearly 700 people worldwide. Our employee-owned structure allows us to operate with a sense of ownership and commitment to excellence.Our clients rely on us for commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness.We prioritize our clients'...

  • Senior Validation Specialist

    5 days ago

    Limerick, Limerick, Ireland CAI Full time

    About CAICAI is a 100% employee-owned company with a strong commitment to safety, quality, and customer satisfaction. Our team of experts provides commissioning, qualification, validation, start-up, project management, and consulting services to FDA-regulated industries.Our ApproachWe put the client's interests first and strive for excellence in everything...

  • Validation Specialist

    2 days ago

    Limerick, Limerick, Ireland CAI Full time

    About CAICAI is a 100% employee-owned company that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.We put the client's interests first, and we do not stop...

  • CQV Professional for Pharmaceutical Plants

    2 days ago

    Limerick, Limerick, Ireland Pm Group Full time

    Company Overview">Pm Group is a leading international engineering, architecture, project, and construction management firm with a strong presence in Europe, Asia, and the US.">We deliver complex, capital projects in various sectors including life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy, and environment.">In response...

  • Senior Downstream Engineer

    4 days ago

    Limerick, Limerick, Ireland PM Group Full time

    At PM Group, we're a leading international engineering firm delivering complex projects in the life sciences sector. Our expertise spans from food and beverages to mission-critical systems and advanced manufacturing.About this role:We're seeking an experienced Senior Downstream Engineer to join our team based onsite with a key client in Limerick. As a...

  • Quality Assurance Engineer

    2 days ago

    Limerick, Limerick, Ireland Pm Group Full time

    About the RoleAs a Senior CQV Engineer, you will be responsible for ensuring that commissioning, installation, and operational qualification (IQ/OQ) of complex process systems are completed efficiently and effectively. Your primary focus will be on downstream purification processes, including filter dryers, nano-filtration units, and header tanks.You will...

  • Validation Engineer Leader

    3 days ago

    Limerick, Limerick, Ireland HERO Recruitment Full time

    Hero Recruitment is seeking an experienced Validation Engineer Leader to lead and execute validation projects, ensuring timely delivery while coordinating across functions. This role involves developing, executing, and managing Test Method Validations to meet stringent quality and regulatory standards.The successful candidate will work closely with Quality,...

  • Validation Engineer Lead

    7 days ago

    Limerick, Limerick, Ireland Réalta Technologies Full time

    Key ResponsibilitiesThe Automation Engineer SME will be responsible for:Configuring and programming biopharma manufacturing equipment used in both upstream and downstream processes, as well as QC lab and analytical equipment.Leading the development and execution of validation protocols for computerized equipment.Providing expert guidance to internal...

  • Senior Downstream Process Engineer

    2 days ago

    Limerick, Limerick, Ireland Pm Group Full time

    Overview">Pm Group is a leading engineering, architecture, project, and construction management firm with a global presence.">We deliver complex, capital projects in various sectors including life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy, and environment.">In response to our success securing large-scale projects, we...

  • Quality / Validation Engineer

    5 days ago

    Limerick, Limerick, Ireland Life Science Recruitment Full time

    Quality Validation EngineerSMC6706Contract - 12 monthsLimerickWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Limerick.This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties: Responsible for supporting the...

  • Process Validation Engineer

    21 minutes ago

    Limerick, Limerick, Ireland Life Science Recruitment Full time

    This is a unique opportunity to join a market-leading Pharmaceutical organization in Ireland. The ideal candidate will have expertise in validation, process engineering, and quality assurance.Main Responsibilities: Execute equipment validation through cycle development, cleaning validation, and performance qualification. Develop and implement validation...