A leading engineering services firm in Ireland is seeking a CQV specialist to conduct and lead commissioning, qualification, and validation activities. The ideal candidate will have a BS or MS in a relevant field and 3+ years of experience in CQV roles for life sciences, preferably with Clean Utilities/Filling experience. Strong communication and problem-solving skills are essential. This role may require travel. The company values diversity and is an equal opportunity employer. #J-18808-Ljbffr
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. 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 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. Responsibilities Conduct and lead Commissioning, Qualification, Validation team activities with a direct regard for Safety. Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion. Generating C&Q Procedures for projects. Approval of TOPs. Facilitate scoping / planning of commissioning spares and consumables. Deliver the C&Q activities as required to meet the schedule Track progress of C&Q activities as required. Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM) Execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities. Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management. Coordinate with project contractors and equipment vendors to execute required tests. Allocate project resources for efficient execution of project deliverables. Coordinate support during C&Q execution Position Requirements BS or MS in a relevant science or engineering field, or equivalent 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable Excellent oral and written communication skills Excellent problem-solving skills Customer-service focused. Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. #J-18808-Ljbffr
A professional services company in Limerick is seeking a Senior IT Applications Analyst to manage the deployment and lifecycle of business-critical applications. You will collaborate with cross-functional teams to gather requirements, provide technical support, and ensure applications operate efficiently. Ideal candidates have a Bachelor’s degree in IT and at least 5 years of relevant experience. This role requires commitment to a 40-hour work week and the ability to travel to client sites as needed. #J-18808-Ljbffr
A global professional services company is seeking a Senior Validation Engineer in Dublin. This role involves leading validation activities, ensuring compliance with GMP standards, and managing project documentation. Candidates should have a bachelor's degree in engineering and 5–10 years of validation experience in the pharmaceutical industry. Strong problem-solving and communication skills are essential. #J-18808-Ljbffr
A professional services company in Dublin seeks a seasoned Validation Engineer to lead commissioning and validation activities for packaging lines. The ideal candidate will ensure compliance with GMP and regulatory standards, support cross-functional teams, and manage validation documentation. Required qualifications include a degree in Engineering and 5-10 years of validation experience in the Pharmaceutical or Life Sciences industry. #J-18808-Ljbffr
A leading company in the life sciences sector is seeking a CQV Engineer to join its growing operations in Ireland. The ideal candidate will oversee Commissioning, Qualification, and Validation activities while managing project documentation and ensuring safety compliance. Candidates should hold a relevant degree and have significant experience in life sciences processes, especially in Clean Utilities and Filling operations. This role offers an opportunity to work with cutting-edge technologies and contribute to lifesaving therapies. #J-18808-Ljbffr
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. 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 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: · Conduct and lead Commissioning, Qualification, Validation team activities with a direct regard for Safety. · Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion. · Generating C&Q Procedures for projects. · Approval of TOPs. · Facilitate scoping / planning of commissioning spares and consumables. · Deliver the C&Q activities as required to meet the schedule · Track progress of C&Q activities as required. · Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM) · Execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities. · Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management. · Coordinate with project contractors and equipment vendors to execute required tests. · Allocate project resources for efficient execution of project deliverables. · Coordinate support during C&Q execution - Position Requirements: · BS or MS in a relevant science or engineering field, or equivalent · 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable · Excellent oral and written communication skills · Excellent problem-solving skills · Customer-service focused. · Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. · 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
Validation Engineer – Senior 3 days ago Be among the first 25 applicants CAI Overview CAI is a professional services company established in 1996 that has grown year over year to nearly 700 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high‑stakes environments, we provide commissioning, qualification, validation, start‑up, project management, and consulting services related to operational readiness for FDA‑regulated and other mission‑critical industries. Our purpose informs everything we do: we exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. At 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 believe in relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t, redefining industry standards entirely. Operational readiness isn’t simply a goal – it’s a way of life. Job Title UKG Validation Engineer Job Details Department: Commissioning, Qualification & Validation Reports To: Senior Validation Manager Job Type: Full‑time Location: Dublin, Ireland Job Summary Lead commissioning, qualification, and validation activities for packaging and combination product assembly lines, ensuring compliance with GMP, data integrity, and regulatory expectations. Support project teams by developing and executing validation protocols, managing documentation, coordinating resources, and ensuring timely delivery of CQV activities. Engage early in projects to provide design input, vendor coordination, and risk mitigation, while partnering with cross‑functional teams to achieve right‑first‑time outcomes. Key Responsibilities Lead end‑to‑end validation activities in a GMP environment with a focus on safety, quality, and compliance. Plan and execute qualifications, oversee FAT/SAT and commissioning activities, and manage deviations/CAPAs. Partner with Engineering, Operations, QA and IT teams to troubleshoot and resolve issues. Create and review validation documentation including VMPs, URS, IQ/OQ, IV/FV, FV, and PQ protocols. Ensure all documentation is audit‑ready and compliant with ALCOA+ principles and data integrity expectations. Qualify packaging equipment such as vial labellers, cartoners, carton labelling systems, vision systems, printers/coders, and associated handling/inspection equipment. Validate serialization and aggregation systems, ensuring data accuracy and regulatory compliance. Support design reviews, shakedown, commissioning, FAT, and IQ/OQ/PQ activities. Support scoping, planning and execution of validation projects, ensuring alignment with project schedules. Lead vendor and stakeholder engagement during FAT/SAT activities to meet project deliverables. Validate market‑specific packaging formats, covering artwork, label content, pack configuration, tamper evidence, variable data and serialization rules. Investigate issues, perform structured root cause analysis (5‑Whys, fault‑tree analysis), and implement corrective actions. Ensure timely CAPA closure and update change control documentation as needed. Qualifications Bachelor’s degree (BS/BA) in Engineering preferred; relevant experience may substitute for education. Minimum 5–10 years of experience in validation roles within the Pharmaceutical/Life Sciences industry. Strong knowledge of packaging equipment, inspection systems and serialization/aggregation solutions. Deep understanding of GMP regulations and data integrity (ALCOA+). Experience in risk‑based validation methods and structured RCA. Strong problem‑solving, planning and organizational skills. Excellent oral and written communication skills. Willingness to collaborate across cross‑functional teams and support multiple projects simultaneously. Preferred Qualifications Technical degree in Engineering. Leadership Competencies Deliver Business Growth Strategies Supports initiatives to balance short‑ and long‑term business goals. Aligns team priorities with broader organizational strategies. Apply Commercial Insights Demonstrates understanding of financial and risk factors impacting business. Supports ongoing risk management. Focus on Customers Promotes a customer‑focused environment. Supports meeting and anticipating customer needs. Lead Execution Maintains accountability and encourages managed risk‑taking. Keeps teams focused and aligned on objectives. Influence and Engage Others Collaborates effectively and cultivates organizational networks. Supports positive negotiation and communication. Build Talent Pursues skill development and supports team growth. Promotes diversity and inclusiveness. Achieve Results with People Inspires commitment and high performance. Encourages continuous learning and improvement. Lead Courageously and Safely Supports a safe, ethical and inclusive culture. Upholds integrity and leads by example. Equal Opportunity Statement CAI is an equal‑opportunity employer, proud to employ veterans and promote diversity in our workplace. We pledge to operate fairly and equitably for all employees, customers, and the broader society. This job description is not all‑inclusive; other duties may be assigned. Recruitment Process We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analysing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgement. Final hiring decisions are ultimately made by humans. #J-18808-Ljbffr
Overview Project / Process Engineer About CAI: CAI is a dynamic, 100% employee-owned company founded in 1996, with over 800 employees globally. We specialize in providing Commissioning, Qualifications, Validation, start-up, project management, and consulting services across FDA regulated and other mission-critical industries. Our Commitment to Excellence At CAI, our commitment is to prioritize our clients\' interests and pursue excellence. We uphold our Foundational Principles: Integrity, Service, Sustainability. We believe employee ownership aligns individual success with collective success and drives teamwork, respect, and a positive can-do attitude. Position Overview We are currently seeking a talented Process Engineer with 2-5 years of experience to join our expanding operations in Ireland. In this role at CAI Ireland, you will: Specifies and designs cGMP process equipment, piping, and control systems. Manages projects of small-to-medium scale related to process equipment and manufacturing. Participates in design reviews, site acceptances, and equipment installation. Revises piping and instrumentation diagrams (P&ID) and associated drawings. Revises Process Flow Diagrams for manufacturing operations. Supports the QA Validation department by preparing design documents and assisting in protocol execution. Investigates process equipment, utility systems, control system issues, and safety incidents. Implements corrective and preventative actions for current equipment and processes. Implements improvements for manufacturing processes and utilities. Prepares engineering evaluations and test plans, and carries out change control documentation. Supervises mechanical, electrical, and automation contractors when needed. Ensures a clean and safe working environment by enforcing procedures, policies, and regulations. Upholds company reputation by ensuring compliance with all relevant laws, policies, and regulations. Identifies opportunities for equipment improvements and the adoption of new technologies. Assists with tech transfer activities, including process scale-up and New Product Introductions (NPIs). Position Requirements To thrive in this role within CAI Ireland, you will need: Requires a BS/BEng in Chemical, Process, or Mechanical engineering with 2-5 years of related experience. Direct experience with biopharmaceutical process equipment is preferred. Relevant experience may substitute for educational requirements. Experience in design and commissioning within the biopharmaceutical sector is desirable. Knowledgeable in CIP systems, bioreactors, centrifuges, chromatography, and ultrafiltration/diafiltration. Strong problem-solving abilities aligned with Ireland\'s regulatory standards. A strong customer-service focus, understanding the Irish market\'s unique needs. Willingness and flexibility to travel within Ireland and potentially internationally if required. #J-18808-Ljbffr
Overview CAI is a professional services company established in 1996 that has grown year over year to nearly 750 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high‑stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field‑tested processes, and elite expertise developed over 30 years. Responsibilities Lead the team onsite in the execution of commissioning activities. Develop project‑specific commissioning management/validation documents and procedures. Lead project commissioning meetings and be confident in your delivery. Develop and prepare reports that include technical content, progress, and issue resolution. Provide technical commentary on drawings, manuals, and technical submittals. Assign tasks to other discipline leads and manage their progress. Vendor coordination and management. Manage the process of QA/QC of MEP equipment/start‑up as needed with your team on projects. Execute test scripts to confirm MEP equipment is functional as per the design specification. Fully adopt the CAI Safety culture by producing task‑specific method statements, JHA’s or other relevant safety documentation. Safety plans prior to project commencement and monthly safety reporting are to be carried out. Provide consultative advice to our clients in determining commissioning and validation requirements, commissioning strategies, methodologies, and streamlining commissioning activities. Awareness of scope change items and report accordingly. Assist the CAI Regional Manager with tender submissions and bids. General understanding of LEED/Green Star specifications and requirements. Position Requirements Bachelor’s degree or equivalent experience. Project skills, PMP or equivalent, beneficial. Knowledge of OSHA (or equivalent) safety requirements. Good written and spoken communication skills. Understanding of project management tools. Knowledge of MS Project. Ability to read electrical schematics and mechanical P&IDs. Strong experience with Word, Excel, and PowerPoint. Can effectively create final deliverables in all three programs. Able to travel domestically and internationally if required. Equal Opportunity 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
