Process Engineer

Arcadis is seeking an experienced Owner‑Side Project Engineer to support the detailed design, Factory Acceptance Testing (FAT), and execution phases—culminating in operational qualification—for a new formulation and sterile supply suite. The successful candidate will work closely with the broader drug product suite project team, providing technical expertise and project leadership across key unit operations including Parts Washer, Autoclave, Single Use Mixers, and associated peripheral equipment.

• Collaborate with design and engineering teams to review and optimize layouts, utilities, and equipment specifications for sterile supply suite components.
• Develop, review, and execute FAT protocols for critical equipment (Parts Washer, Autoclave, Single Use Mixers, peripherals).
• Oversee equipment installation, commissioning, and qualification (OQ), ensuring compliance with owner requirements and regulatory standards.
• Act as the technical liaison between the owner’s team and EPC/design contractors, ensuring project objectives are met.
• Work as an embedded member of the larger drug product suite project team, supporting cross‑functional project delivery.
• Ensure project documentation, protocols, and qualification records are complete and audit‑ready.
• Other duties as assigned.

• 5–10 years in pharmaceutical capital projects, with direct exposure to unit operations such as Parts Washer, Autoclave, Single Use Mixers, and peripheral process equipment.
• Strong understanding of GMP environments, sterile processing, and equipment qualification practices.
• Proven ability to deliver projects through detailed design, FAT, installation, and operational qualification.
• Effective communicator and collaborator, able to work within multidisciplinary teams and interface with external contractors.
• Familiarity with FDA, EU GMP Annex 1, and other relevant regulatory frameworks.
• Bachelor’s degree or higher in Engineering, Life Sciences, or related field.
• Experience acting in an owner‑side engineering capacity on pharmaceutical capital projects.