Senior C&Q Engineer

Limerick, PA - USA

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

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 weve challenged ourselves to do what others wouldnt. 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 isnt simply a goal. Its 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. Were not interested in how it used to be done. Were 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.

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.

Required Experience:

Senior IC

CAI Overview Are You ReadyCAI 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 ...