Capital Project Engineer (Clean Utilities)

Arcadis; Holly Springs (NC); Sur place; USD 80 000 - 120 000; Plein temps

Avantages offerts par ce poste

Medical Insurance

Dental Insurance

Vision Insurance

401K

Paid Leave

Résumé du poste

An established industry player is looking for a Senior Project Engineer to support the expansion of a brownfield biotech facility. This exciting role involves developing technical deliverables for clean utility systems, collaborating with various teams to ensure operational readiness, and overseeing system validation in compliance with regulatory standards. The ideal candidate will have extensive experience in project engineering within regulated environments, particularly in biotech or pharmaceuticals. Join a forward-thinking company committed to sustainability and diversity, and make a significant impact in the life sciences sector.

Qualifications

• 5+ years in biotech or pharmaceutical manufacturing environments.
• Extensive experience with Clean Utility systems in Life Science projects.

Responsabilités

• Serve as a technical SME for clean utility system queries.
• Coordinate with construction teams to resolve design challenges.
• Oversee system validation and ensure compliance with standards.

Connaissances

Project Engineering

Clean Utility Systems

Problem-solving

Regulatory Compliance

Collaboration

Formation

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Mechanical Engineering

Description du poste

Job Description: Senior Project Engineer at Arcadis

Arcadis, the world's leading company in sustainable design, engineering, and consultancy solutions for natural and built assets, is seeking a Senior Project Engineer to support a brownfield biotech facility expansion focused on cGMP bulk drug substance manufacturing.

This role involves developing technical deliverables across various lifecycle phases for clean utility systems, including clean steam, WFI, purified water, clean compressed air, and HVAC systems. The candidate will collaborate with Engineering, Manufacturing, Facilities, and Quality teams to ensure systems are implemented, qualified, and maintained for operational readiness.

Key Responsibilities

1. Serve as a technical SME for all clean utility system queries from A/E firms and clients.
2. Provide expertise in design, modification, and integration of clean utility systems.
3. Review design drawings, P&IDs, and system layouts to ensure compliance and adequacy.
4. Coordinate with construction teams to resolve design and installation challenges.
5. Support the transfer of knowledge from design to construction phases.
6. Oversee system validation, including FAT plans and technical specifications.
7. Ensure all systems meet regulatory, environmental, and safety standards.
8. Collaborate with project teams to execute system upgrades within active facilities.
9. Lead Utilities CQV efforts, including testing and balancing.
10. Ensure proper documentation, SOPs, and process flow diagrams are in line with cGMP standards.
11. Partner with EH&S teams to ensure compliance with environmental and safety regulations.
12. Verify systems are ready for handover to manufacturing and maintenance teams.

Qualifications & Experience

• Bachelor’s degree in Chemical or Mechanical Engineering or related field.
• Minimum of 5 years in biotech, pharmaceutical, or regulated manufacturing environments, especially in brownfield projects.
• Extensive experience in Project Engineering for Clean Utility systems in Life Science projects.
• Strong knowledge of WFI, purified water, clean steam, compressed air, and HVAC systems.
• Familiarity with GMP, cGMP, ISPE guidelines, and regulatory standards.
• Ability to manage multiple priorities in a fast-paced environment.
• Problem-solving skills and hands-on troubleshooting experience.

Additional Information

Arcadis offers a comprehensive benefits package, including medical, dental, vision, 401K, paid leave, and more. We are committed to diversity, equity, and inclusion, welcoming applicants from all backgrounds.