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:
1. Integrity: We act with the utmost integrity.
2. Service: We serve one another and society.
3. 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:
1. Specify and design cGMP process equipment, piping, and control systems.
2. Manage projects of small-to-medium scale related to process equipment and manufacturing.
3. Participate in design reviews, site acceptances, and equipment installation.
4. Revise piping and instrumentation diagrams (P&ID) and associated drawings.
5. Revise Process Flow Diagrams for manufacturing operations.
6. Support the QA Validation department by preparing design documents and assisting in protocol execution.
7. Investigate process equipment, utility systems, control system issues, and safety incidents.
8. Implement corrective and preventative actions for current equipment and processes.
9. Implement improvements for manufacturing processes and utilities.
10. Prepare engineering evaluations and test plans, and carry out change control documentation.
11. Supervise mechanical, electrical, and automation contractors when needed.
12. Ensure a clean and safe working environment by enforcing procedures, policies, and regulations.
13. Uphold company reputation by ensuring compliance with all relevant laws, policies, and regulations.
14. Identify opportunities for equipment improvements and the adoption of new technologies.
15. Assist 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:
1. 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.
2. Experience in design and commissioning within the biopharmaceutical sector is desirable.
3. Knowledgeable in CIP systems, bioreactors, centrifuges, chromatography, and ultrafiltration/diafiltration.
4. Strong problem-solving abilities aligned with Ireland's regulatory standards.
5. A strong customer-service focus, understanding the Irish market's unique needs.
6. Willingness and flexibility to travel within Ireland, potentially internationally if required.
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