Senior Process Engineer

Job description

**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, 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.