Senior Process Engineer

Limerick, PA - USA

Monthly Salary: Not Disclosed

Posted on: 7 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: 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.

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 ...