Process Engineer - Biopharmaceutical Commissioning & Qualification

About CAI

CAI is a 100% employee-owned enterprise, established in 1996, employing over 800 people worldwide. We specialize in services such as Commissioning, Qualification, Validation, project startup, management, and consulting, particularly within FDA-regulated and other critical industries. Our offices operate across the US, Singapore, Australia, Ireland, and Europe.

Our Core Values

• Integrity: Maintaining highest ethical standards.
• Service: Commitment to helping colleagues, clients, and communities.
• Sustainability: Dedicated to long-term success and future-focused practices.

Success at CAI is cultivated through teamwork, respect, and proactive attitudes that drive both individual and collective accomplishment.

Role Summary

The role focuses on senior-level engineering for Process and Commissioning & Qualification (C&Q) within an expanding biopharmaceutical initiative. Key responsibilities cover upstream and downstream bioprocess operations including handling equipment such as bioreactors ranging from 10 liters to large scale, filtration systems, and related complex machinery supporting full lifecycle C&Q aligned with GMP drug manufacturing standards.

Key Responsibilities

• Lead design stages from conceptual to detailed for process equipment and utilities.
• Manage full C&Q lifecycle for biopharmaceutical equipment like bioreactors, filtration skids, tank farms, autoclaves, parts washers, and CIP systems.
• Prepare, review, and execute commissioning and qualification protocols (IQ/OQ/PQ).
• Take an active role throughout project stages from design to handover.
• Work cross-functionally with Process Engineering, Automation, Manufacturing, PDTS, and Validation teams to implement improvements.
• Comply with EHS regulations, cGMP, and Good Engineering Practices consistently.
• Coordinate engineering consultants, vendors, and contractors effectively.
• Provide expert advice on upstream and downstream bioprocess operations supporting project and equipment development.

Qualification Requirements

• Bachelor’s degree in Chemical, Biotechnology, or Biochemical Engineering.
• Minimum 3–5 years’ practical experience primarily in downstream bioprocess operations; upstream operations experience is advantageous.
• Strong proficiency in commissioning and qualification across biopharmaceutical equipment lifecycle.
• Experience with bioreactors and filtration systems including protocol development and execution.
• Background working in cGMP manufacturing environments within pharmaceutical or biotech sectors.
• Familiarity with PCS7 functional specifications; Siemens PCS7 expertise preferred, DeltaV knowledge beneficial.
• Understanding of sanitary design and operational principles for biopharmaceutical manufacturing equipment.
• Excellent verbal and written communication skills in English.
• Competency in Microsoft Office applications.
• Willing to travel up to 50% of the time.

Preferred Experience

• Senior-level experience in C&Q with hands-on execution abilities.
• Comprehensive exposure to upstream and downstream processes, specifically bioreactor and filtration technologies.
• Demonstrable success in delivering GMP-compliant projects within biotechnology or pharmaceutical manufacturing.

Additional Information

Artificial intelligence tools may be utilized during the selection process to screen applications and support recruitment efforts, but hiring decisions are always finalized by human personnel. Candidates may inquire further regarding data usage.