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 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.
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