Senior Process Engineer

About CAI

CAI is a global professional services firm founded in 1996 that has expanded steadily to a workforce of nearly 800 people. The company supports Life Sciences and Mission Critical organizations that must deliver vital outcomes in demanding environments, helping them achieve faster operational readiness and high-performance execution through disciplined methods, proven processes, and specialized expertise built over three decades.

Its purpose-driven culture centers on being a dependable partner for clients working to build a better workplace and improve the human experience. CAI says its work is guided by four foundational principles: acting with integrity, serving one another, serving society, and building for the future.

The organization emphasizes excellence, innovation, and continuous improvement, combining practical experience with technology to improve how critical operations are delivered.

Role Overview

CAI is looking for an experienced Process Engineer with deep upstream and downstream bioprocessing experience to support complex GMP manufacturing projects in a biopharmaceutical setting. The position is focused on bioreactor systems and purification processes, covering work from process design through commissioning, qualification, and handover to operations.

The successful candidate will contribute to process optimization, equipment commissioning, and validation across upstream fermentation and downstream purification activities, supporting drug substance manufacturing for global supply.

Key Responsibilities

• Provide engineering support for upstream bioreactor operations, including seed train activities and large-scale production bioreactors.
• Assist with downstream processing such as centrifugation, filtration, chromatography, and ultrafiltration/diafiltration (UF/DF).
• Contribute to process scale-up, technology transfer, and new product introduction work.
• Lead or support troubleshooting, investigations, and continuous improvement efforts.
• Drive and assist with the full commissioning and qualification lifecycle.
• Write, review, and carry out IQ, OQ, PQ, and commissioning protocols.
• Take part in FAT, SAT, site acceptance, and equipment installation activities.
• Support QA validation teams with process records and technical input.
• Specify and review cGMP process equipment, piping, and control systems.
• Review and revise P&IDs and process flow diagrams (PFDs).
• Prepare engineering assessments, technical risk reviews, and change control documents.
• Maintain compliance with GMP, safety, and regulatory requirements.
• Support investigations related to process deviations, equipment problems, and safety incidents, including implementation of CAPAs.

Qualifications

• A degree in Chemical, Process, or Mechanical Engineering, or equivalent relevant experience.
• At least 5 years of experience in a biopharmaceutical or GMP-regulated environment.
• Practical experience in both upstream and downstream bioprocess operations.
• Hands-on exposure to bioreactors, centrifugation, filtration, chromatography, and UF/DF.
• Good understanding of CIP systems and clean utility design.
• Background supporting GMP pharmaceutical or biotechnology manufacturing projects.
• Strong communication skills and a customer-oriented approach.
• Availability to travel within Ireland and internationally when needed.

Additional Requirements

• This is a site-based position.
• Candidates must be able to work at least 40 hours per week, with flexibility depending on project demands.
• Applicants must be eligible to work full-time in Ireland.
• Travel within Ireland and abroad may be required.

Hiring Note

CAI states that AI tools may be used to assist with parts of the hiring process, including resume review, application analysis, response assessment, and identifying possible inconsistencies or verification signals in submitted materials. These tools support the recruitment team but do not replace human judgment, and final hiring decisions are made by people.