CAI Overview
Are You Ready?
CAI is a professional services company established in **** 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 experiencedProcess Engineerwith strongupstream and downstream bioprocessing experienceto support complex GMP manufacturing projects within a leading biopharmaceutical environment.
This role is heavily focused onbioreactor systems, upstream and downstream purification processes, supporting activities fromprocess design through commissioning, qualification, and operational handover.
The successful candidate will play a key role inprocess 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 forupstream bioreactor operations(including: Seed train operations, Large-scale production bioreactors).
·Supportdownstream processing(including: Centrifugation, Filtration systems, Chromatography, Ultrafiltration / Diafiltration (UF/DF)).
·Supportprocess scale-up, technology transfer, and Current Product Introduction (NPI)activities.
·Lead and supportprocess troubleshooting, investigations, and continuous improvement initiatives.
·Lead and supportfull lifecycle commissioning & qualification (C&Q;)activities.
·Author, review, and executeIQ/OQ/PQ and commissioning protocols.
·Participate inFAT, SAT, site acceptance, and equipment installation activities.
·Support QA Validation teams by providingprocess documentation and technical expertise.
·Specify and reviewcGMP process equipment, piping, and control systems.




·Review and updateP&IDs; and Process Flow Diagrams (PFDs).
·Prepareengineering evaluations, technical risk assessments, and change control documentation.
·Ensure full compliance withGMP, safety, and regulatory standards.
·Support investigations intoprocess deviations, equipment issues, and safety events, implementing CAPAs.

Qualifications
Degree-qualifiedin Chemical, Process, or Mechanical Engineering (or equivalent experience).
5+ years' experiencein abiopharmaceutical or GMP-regulated environment.
Strong hands-on experience inboth upstream and downstream bioprocess operations.
Proven experience withBioreactors, centrifugation, filtration, chromatography, and UF/DF
Solid understanding ofCIP systems and clean utility design.
Experience supportingGMP pharmaceutical or biotech manufacturing projects.
Excellent communication skills with a strongcustomer-focused mindset.
Willingness totravel within Ireland and internationallywhen 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 withinIreland and internationally, if required.
·Eligible to work full-time in Ireland.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. 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.

📌 Senior Process Engineer (Melbourne)
🏢 Cagents
📍 Melbourne