Arcadis · 1 hour ago
Process Engineer
Arcadis is seeking an experienced Owner-Side Project Engineer to support the detailed design and execution phases for a new formulation and sterile supply suite. The role involves providing technical expertise and project leadership across key unit operations, ensuring compliance with regulatory standards, and collaborating with various teams to optimize project delivery.
Responsibilities
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
Qualification
Required
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
Company
Arcadis
Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.
H1B Sponsorship
Arcadis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (126)
2024 (69)
2023 (69)
2022 (69)
2021 (72)
2020 (103)
Funding
Current Stage
Public CompanyTotal Funding
$0.03M2017-06-01Grant· $0.03M
1995-10-06IPO
Recent News
2025-12-30
2025-12-25
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