Senior Process / Commissioning & Qualification Engineer – Biopharmaceuticals

About CAI

CAI is a global, employee-owned company established in 1996 and employing more than 800 people worldwide. The business delivers commissioning, qualification, validation, startup, project management, and consulting services for FDA-regulated and other highly critical industries. Its footprint includes locations in the United States, Singapore, Australia, Ireland, and across North and South Europe.

Role Summary

This opening is for an experienced Process / C&Q Engineer to support a biopharmaceutical program covering both upstream and downstream operations. The assignment includes work on bioreactors ranging from 10L to very large-scale vessels, filtration systems, and other specialized process equipment, with responsibility across the full commissioning and qualification lifecycle for GMP manufacturing.

Key Responsibilities

The engineer will contribute from early design through to project closeout, supporting process systems, utilities, and regulated manufacturing equipment. The role requires coordination with multiple internal and external stakeholders while maintaining compliance with EHS, cGMP, and GEP standards.

• Develop conceptual, basic, and detailed designs for process equipment and utilities.
• Support end-to-end commissioning and qualification of biopharmaceutical systems such as bioreactors, filtration skids, tank farms, autoclaves, parts washers, and clean-in-place systems.
• Prepare, review, and carry out qualification documentation and protocols, including IQ, OQ, and PQ.
• Take part in design, commissioning, qualification, and handover activities throughout the project lifecycle.
• Work closely with Process Engineering, Automation, Manufacturing, PDTS, and Validation teams to implement process improvements and changes.
• Ensure work is aligned with applicable environmental, health and safety requirements, current GMP, and good engineering practices.
• Manage and coordinate engineering and construction consultants, equipment suppliers, and contractors.
• Apply process knowledge in both upstream and downstream bioprocessing to support equipment design and project delivery.

Required Qualifications

• Bachelor’s degree in Chemical, Biotechnology, or Biochemical Engineering.
• At least 3–5+ years of practical experience in downstream bioprocess operations; upstream exposure is an advantage.
• Strong background in full-lifecycle commissioning and qualification of biopharmaceutical equipment.
• Proven experience with bioreactors and filtration systems, including writing and executing protocols.
• Previous work supporting cGMP manufacturing in pharmaceutical or biotech facilities.
• Understanding of PCS7 functional specifications; Siemens PCS7 knowledge is preferred and DeltaV familiarity is beneficial.
• Working knowledge of design principles, sanitary design, and operation of biopharmaceutical manufacturing equipment.
• Excellent written and verbal English communication skills.
• Comfortable using MS Office applications.
• Willing to travel up to 50%.

Preferred Experience

• Senior-level C&Q background with practical execution experience.
• Exposure to both upstream and downstream processing, especially bioreactors and filtration systems.
• Demonstrated success on GMP biotech or pharmaceutical projects.

Additional Information

CAI emphasizes integrity, service, and sustainability as its core principles. The company values teamwork, respect, a positive attitude, and a strong commitment to client success.

AI-Assisted Hiring Notice

AI tools may be used to help with parts of the recruitment process, including reviewing applications, analysing resumes, checking responses, and identifying possible inconsistencies or verification signals from the information provided. These tools support the recruiting team but do not replace human judgment. Final hiring decisions are made by people. Applicants may contact the company for more details about data handling.