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:
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 and downstream 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.
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