The Process Engineer will design cGMP systems, manage related projects, support QA validation, and oversee compliance with regulations.
**Project / Process Engineer**
About CAI
CAI is a dynamic, 100% employee-owned company founded in 1996, that has grown year over year to now encompass over 800 employees globally. We specialize in providing Commissioning, Qualifications, Validation, start-up, project management, and consulting services across FDA regulated and other mission-critical industries.
Our Commitment to Excellence
At CAI, our unwavering commitment is to prioritize our clients' interests. We persist until we achieve excellence, going above and beyond to deliver exceptional results. As CAI owners, we uphold our Foundational Principles both professionally and personally:
· Integrity: We act with the utmost integrity.
· Service: We serve one another and society.
· Sustainability: We work for our future.
We firmly believe that in employee ownership, individual success translates into collective success. We relentlessly pursue team objectives, valuing teamwork, respect for others, and a positive can-do attitude. This synergy has driven our exponential growth.
Position Overview
We are currently seeking a talented Process Engineer with 2-5 years’ experience to join our expanding operations in Ireland. In this role at CAI Ireland, you will:
· Specifies and designs cGMP process equipment, piping, and control systems.
· Manages projects of small-to-medium scale related to process equipment and manufacturing.
· Participates in design reviews, site acceptances, and equipment installation.
· Revises piping and instrumentation diagrams (P&ID) and associated drawings.
· Revises Process Flow Diagrams for manufacturing operations.
· Supports the QA Validation department by preparing design documents and assisting in protocol execution.
· Investigates process equipment, utility systems, control system issues, and safety incidents.
· Implements corrective and preventative actions for current equipment and processes.
· Implements improvements for manufacturing processes and utilities.
· Prepares engineering evaluations and test plans, and carries out change control documentation.
· Supervises mechanical, electrical, and automation contractors when needed.
· Ensures a clean and safe working environment by enforcing procedures, policies, and regulations.
· Upholds company reputation by ensuring compliance with all relevant laws, policies, and regulations.
· Identifies opportunities for equipment improvements and the adoption of new technologies.
· Assists with tech transfer activities, including process scale-up and New Product Introductions (NPIs).
Position Requirements
To thrive in this role within CAI Ireland, you will need:
· Requires a BS/BEng in Chemical, Process, or Mechanical engineering with 2-5 years of related experience. Direct experience with biopharmaceutical process equipment is preferred. Relevant experience may substitute for educational requirements.
· Experience in design and commissioning within the biopharmaceutical sector is desirable.
· Knowledgeable in CIP systems, bioreactors, centrifuges, chromatography, and ultrafiltration/diafiltration
· Strong problem-solving abilities aligned with Irelands regulatory standards.
· A strong customer-service focus, understanding the Irish market's unique needs.
· Willingness and flexibility to travel within Ireland potentially internationally if required.
Top Skills
Bioreactors
Centrifuges
Cgmp Process Equipment
Chromatography
Cip Systems
Control Systems
Diafiltration
Piping
Ultrafiltration
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