Senior Project Engineer (Clean Utilities)

TL;DR

Senior Project Engineer (Clean Utilities): Leading the end-to-end engineering, execution, and delivery of clean utility systems for complex pharmaceutical manufacturing projects with an accent on compliance, sustainability, and operational excellence. Focus on serving as the Subject Matter Expert for systems like WFI, PW, and PS, while managing cross-functional interfaces and large-scale CAPEX project scopes.

Location: On-site in Holly Springs, North Carolina, USA. No remote options available.

Salary: $90,600 - $168,200

Company

hirify.global, a member of the Roche group, is a pioneer in the biotechnology industry dedicated to discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Provide technical oversight and system ownership for clean utility systems including WFI, PW, PS, and process waste.
• Define system concepts, specifications, and URS ensuring robust hygienic design and microbial control.
• Lead clean utility scopes in large CAPEX projects from concept development through commissioning and qualification.
• Review and approve engineering deliverables such as P&IDs, control philosophies, and automation concepts.
• Manage cross-functional interfaces with EPCM firms, OEMs, and equipment suppliers to ensure project alignment.
• Act as technical lead for commissioning, qualification, and validation activities including DQ, FAT, SAT, IQ, OQ, and PQ.

Requirements

• Bachelor's or Master's Degree in Mechanical, Chemical, or Process Engineering.
• 5+ years of experience in pharmaceutical, biotechnology, or life science industries.
• Proven expertise in the design, execution, and validation of clean utility systems.
• Strong knowledge of European GMP requirements, FDA regulations, and hygienic design principles.
• Willingness to travel extensively (50%+) for on-site project activities and international assignments.
• Must be based in or able to work on-site in Holly Springs, NC.

Culture & Benefits

• Competitive salary with discretionary annual bonus based on performance.
• Comprehensive benefits package including health insurance and retirement plans.
• Opportunity to work on groundbreaking science and transformational pharmaceutical discoveries.
• Collaborative environment with a focus on innovation and operational excellence.