The Process Engineer will manage small-to-medium scale projects, specify process equipment, revise diagrams, support QA Validation, and ensure compliance with regulations.
Process / Commissioning & Qualification (C&Q) Engineer – Biopharmaceuticals
About CAI
CAI is a dynamic, 100% employee-owned company founded in 1996, now encompassing over 800 employees globally. We specialize in Commissioning, Qualification, Validation, start-up, project management, and consulting services across FDA-regulated and other mission-critical industries. Our offices span the United States, Singapore, Australia, Ireland, and across North & South Europe. Learn more at www.commissioningagents.com.
Our Commitment to Excellence:
At CAI, we prioritize our clients’ success and persist until excellence is achieved. As employee-owners, we uphold our Foundational Principles:
Integrity: We act with the utmost integrity.
Service: We serve one another, our clients, and society.
Sustainability: We work for our future.
We believe that individual success drives collective success. Teamwork, respect, and a positive can-do attitude fuel our growth and client satisfaction.
Position Overview:
We are seeking Senior Process / C&Q Engineers to join our expanding operations, supporting an exciting biopharmaceutical project focused on both upstream and downstream operations. This role involves working with bioreactors (10L to tens of thousands of litres), filtration systems, and other complex equipment, supporting full lifecycle Commissioning & Qualification (C&Q) for GMP drug manufacturing.
Responsibilities:
Lead conceptual, basic, and detailed design for process equipment and utilities.
Support full lifecycle Commissioning & Qualification (C&Q) of complex biopharmaceutical equipment, including bioreactors, filtration skids, tank farms, autoclaves, parts washers, and CIP systems.
Author, review, and execute C&Q protocols (IQ/OQ/PQ).
Participate actively in all project phases: design, commissioning, qualification, and handover.
Collaborate with multi-disciplinary teams, including Process Engineering, Automation, Manufacturing, PDTS, and Validation, to implement improvements and changes.
Ensure compliance with applicable EHS requirements, cGMP, and Good Engineering Practices (GEP).
Coordinate and manage engineering and construction consultants, equipment vendors, and contractors.
Provide process expertise in upstream and downstream bioprocess operations to support equipment design and project implementation.
Required Qualifications:
Bachelor’s degree in Chemical, Biotechnology, or Biochemical Engineering.
3–5+ years of hands-on experience in downstream bioprocess operations; upstream experience is a plus.
Strong background in full lifecycle commissioning & qualification of biopharmaceutical equipment.
Demonstrated experience with bioreactors and filtration systems, including protocol writing and execution.
Experience supporting cGMP manufacturing operations in pharmaceutical or biotech facilities.
Knowledge of PCS7 functional specifications; Siemens PCS7 experience preferred. Knowledge of DeltaV is a plus.
Familiarity with design principles, sanitary design, and operation of biopharmaceutical manufacturing equipment.
Strong written and verbal communication skills in English.
Proficiency with MS Office.
Willingness to travel up to 50%.
Preferred Experience:
Senior-level C&Q engineer background with hands-on execution experience.
Exposure to both upstream and downstream processes, especially bioreactors and filtration systems.
Proven track record in GMP biotech/pharma projects.
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