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. #LI-JD1$1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Process / Commissioning & Qualification (C&Q) Engineer - Biopharmaceuticals About CAI CAI is a dynamic, 100% employee-owned company founded in 1996, now encompassing over 800 employees globally. We specialize in Commissioning, Qualification, Validation, start-up, project management, and consulting services across FDA-regulated and other mission-critical industries. Our offices span the United States, Singapore, Australia, Ireland, and across North & South Europe. Learn . Our Commitment to Excellence: At CAI, we prioritize our clients' success and persist until excellence is achieved. As employee-owners, we uphold our Foundational Principles: Integrity: We act with the utmost integrity. Service: We serve one another, our clients, and society. Sustainability: We work for our future. We believe that individual success drives collective success. Teamwork, respect, and a positive can-do attitude fuel our growth and client satisfaction. Position Overview: We are seeking Senior Process / C&Q Engineers to join our expanding operations, supporting an exciting biopharmaceutical project focused on both upstream and downstream operations. This role involves working with bioreactors (10L to tens of thousands of litres), filtration systems, and other complex equipment, supporting full lifecycle Commissioning & Qualification (C&Q) for GMP drug manufacturing. Responsibilities: Lead conceptual, basic, and detailed design for process equipment and utilities. Support full lifecycle Commissioning & Qualification (C&Q) of complex biopharmaceutical equipment, including bioreactors, filtration skids, tank farms, autoclaves, parts washers, and CIP systems. Author, review, and execute C&Q protocols (IQ/OQ/PQ). Participate actively in all project phases: design, commissioning, qualification, and handover. Collaborate with multi-disciplinary teams, including Process Engineering, Automation, Manufacturing, PDTS, and Validation, to implement improvements and changes. Ensure compliance with applicable EHS requirements, cGMP, and Good Engineering Practices (GEP). Coordinate and manage engineering and construction consultants, equipment vendors, and contractors. Provide process expertise in upstream and downstream bioprocess operations to support equipment design and project implementation. Required Qualifications: Bachelor's degree in Chemical, Biotechnology, or Biochemical Engineering. 3-5+ years of hands-on experience in downstream bioprocess operations; upstream experience is a plus. Strong background in full lifecycle commissioning & qualification of biopharmaceutical equipment. Demonstrated experience with bioreactors and filtration systems, including protocol writing and execution. Experience supporting cGMP manufacturing operations in pharmaceutical or biotech facilities. Knowledge of PCS7 functional specifications; Siemens PCS7 experience preferred. Knowledge of DeltaV is a plus. Familiarity with design principles, sanitary design, and operation of biopharmaceutical manufacturing equipment. Strong written and verbal communication skills in English. Proficiency with MS Office. Willingness to travel up to 50%. Preferred Experience: Senior-level C&Q engineer background with hands-on execution experience. Exposure to both upstream and downstream processes, especially bioreactors and filtration systems. Proven track record in GMP biotech/pharma projects. #LI-JD1$1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
CAI Overview Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 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. Our approach is simple because 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 At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we've challenged ourselves to do what others wouldn't. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn't simply a goal. It's a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We're not interested in how it used to be done. We're obsessed with how it will be done. Job Title: Process Engineer Location: Limerick Contract Type: Staff or Contract Job Summary We are currently seeking an experienced Process Engineer with strong upstream and downstream bioprocessing experience to support complex GMP manufacturing projects within a leading biopharmaceutical environment. This role is heavily focused on bioreactor systems, upstream and downstream purification processes, supporting activities from process design through commissioning, qualification, and operational handover. The successful candidate will play a key role in process optimization, equipment commissioning, and validation, working across both upstream fermentation and downstream purification operations, ultimately supporting drug substance production for global supply. Key Responsibilities Provide process engineering support for upstream bioreactor operations (including: Seed train operations, Large-scale production bioreactors). Support downstream processing (including: Centrifugation, Filtration systems, Chromatography, Ultrafiltration / Diafiltration (UF/DF)). Support process scale-up, technology transfer, and New Product Introduction (NPI) activities. Lead and support process troubleshooting, investigations, and continuous improvement initiatives. Lead and support full lifecycle commissioning & qualification (C&Q) activities. Author, review, and execute IQ/OQ/PQ and commissioning protocols. Participate in FAT, SAT, site acceptance, and equipment installation activities. Support QA Validation teams by providing process documentation and technical expertise. Specify and review cGMP process equipment, piping, and control systems. Review and update P&IDs and Process Flow Diagrams (PFDs). Prepare engineering evaluations, technical risk assessments, and change control documentation. Ensure full compliance with GMP, safety, and regulatory standards. Support investigations into process deviations, equipment issues, and safety events, implementing CAPAs. Qualifications Degree-qualified in Chemical, Process, or Mechanical Engineering (or equivalent experience). 5+ years' experience in a biopharmaceutical or GMP-regulated environment. Strong hands-on experience in both upstream and downstream bioprocess operations. Proven experience with Bioreactors, centrifugation, filtration, chromatography, and UF/DF Solid understanding of CIP systems and clean utility design. Experience supporting GMP pharmaceutical or biotech manufacturing projects. Excellent communication skills with a strong customer-focused mindset. Willingness to travel within Ireland and internationally when required. Other Requirements This is a site-based role. Must be able to commit to a minimum 40-hour work week, with flexibility based on project needs. Willingness to travel within Ireland and internationally, if required. Eligible to work full-time in Ireland.$1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Validation Engineer - Senior CAI Overview: Are You Ready? 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 approach is simple because 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 At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we've challenged ourselves to do what others wouldn't. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn't simply a goal. It's a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency, and an unwavering belief that there is always room for advancement. We're not interested in how it used to be done. We're obsessed with how it will be done. Job Title UKG: Validation Engineer Alternate Job Title: N/A 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: Support C&Q Team Activities 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. Documentation and Procedure Support Create and review validation documentation including Validation Master Plans (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. Equipment Qualification and Testing Support 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. Project Planning and Progress Tracking 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. Deviation and CAPA Control 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. 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.$1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
Job Description: Senior IT Applications Analyst CAI Overview Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 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. Our approach is simple because 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 At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we've challenged ourselves to do what others wouldn't. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn't simply a goal. It's a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We're not interested in how it used to be done. We're obsessed with how it will be done. Job Summary The Senior IT Applications Analyst plays a key role in the deployment and lifecycle management of business-critical IT applications. This individual will partner with cross-functional teams to gather requirements, configure systems, manage upgrades, and provide expert-level support, ensuring that applications operate securely, efficiently, and in line with client needs. Key Responsibilities Collaborate with business users and internal stakeholders to collect requirements, assess improvement opportunities, and implement approved system changes. Serve as the primary technical contact and subject matter expert for assigned applications and related projects. Create and maintain technical documentation, including detailed design specifications, configuration plans, testing protocols, and system summaries. Develop and adjust reports and dashboards to support operational and compliance requirements. Oversee the change-control process for IT applications, ensuring that modifications meet established quality and regulatory standards. Coordinate closely with validation and quality teams to support system testing and ensure adherence to the software development life cycle (SDLC). Mentor junior team members, provide application training, and share best practices across the IT department. Manage application security, including user access controls, periodic audits, and data integrity reviews. Provide advanced troubleshooting and technical support for end users, resolving issues at the application or server level. Prioritize daily activities for IT team members to ensure efficient resolution of application-related issues. Maintain accurate training records and ensure compliance with internal procedures. Contribute to continuous improvement initiatives and take on additional tasks as required. Qualifications Bachelor's degree in Information Technology, Computer Science, or a related discipline, or equivalent experience. At least 5 years of hands-on experience supporting or implementing enterprise IT applications. Demonstrated project management skills; professional certifications are a plus. Strong understanding of SDLC methodologies, IT change management, and system validation practices. Excellent analytical, organizational, and communication skills, with the ability to work independently and within a team environment. Other Requirements Must be able to commit to a minimum 40-hour work week, with flexibility to meet project needs. Willingness and ability to travel to client sites as required. Must be eligible to work in the EU without the need for visa sponsorship, now or in the future. #LI-JD1$1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
CAI Overview Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 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. Our approach is simple because 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 At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we've challenged ourselves to do what others wouldn't. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn't simply a goal. It's a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We're not interested in how it used to be done. We're obsessed with how it will be done. Job Title: C&Q Engineer Location: Limerick Contract Type: Staff or Contract Job Summary We are seeking Senior Commissioning & Qualification (C&Q) Engineers with strong hands-on experience across both upstream and downstream bioprocessing to support a large-scale, high-profile biopharma project. The core focus of this project is the commissioning and qualification of bioreactor systems, ranging from small-scale units up to large commercial-scale systems. The role also includes upstream anddownstream process equipment, supporting material flow through filtration and concentration systems, resulting in small-volume, high-value product that is shipped to Western Europe for final drug product manufacturing. This is a high-impact, technically challenging role, ideal for senior-level C&Q professionals seeking involvement in cutting-edge biomanufacturing projects. Key Responsibilities Lead and execute full lifecycle Commissioning & Qualification (C&Q) activities for upstream and downstream process equipment. Commission and qualify bioreactor systems, ranging from small development scale to large commercial-scale reactors. Support downstream processing (including: Filtration systems (TFF / UF / DF), Concentration and purification systems. Review and execute C&Q documentation (including: Commissioning Plans, System Impact Assessments (SIA), Risk Assessments (FMEA), IQ, OQ, and PQ protocols, Traceability matrices and final reports. Ensure all activities comply with GMP regulatory requirements. Collaborate cross-functionally with Engineering, Automation, Validation, QA, Manufacturing, and Project teams. Support deviations, change controls, CAPAs, and regulatory inspections. Qualifications Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline 5+ years' experience in Commissioning & Qualification / CQV / Validation Strong working knowledge of GMP requirements, FDA and EMA regulations Strong hands-on upstream and downstream bioprocess knowledge Extensive experience working with Bioreactors, Filtration and concentration systems Excellent documentation, communication, and stakeholder engagement skills Other Requirements This is a site-based role. Must be able to commit to a minimum 40-hour work week, with flexibility based on project needs. Willingness to travel within Ireland and internationally, if required. Eligible to work full-time in Ireland.$1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
