Senior Project Engineer Clean Utilities

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 91,000 - 168,000; Full time

Job summary

Genentech in North Carolina seeks a Senior Project Engineer for Clean Utilities to own end-to-end engineering and delivery of WFI, PW, PS, and other clean utility systems for complex pharmaceutical manufacturing projects.

You will provide SME-level oversight, coordinate with EPCM firms and vendors, lead commissioning/qualification activities (DQ/IQ/OQ/PQ), ensure hygienic design and GMP compliance, and travel roughly 50% for on-site work and international deployments.

Qualifications

• Bachelor's or Master's degree in Mechanical, Chemical, or Process Engineering required.
• 5+ years of experience in pharmaceutical, biotechnology, or life sciences industries with clean utilities design, execution and validation.
• Strong knowledge of European GMP, FDA regulations, and hygienic design principles (ASME BPE, EHEDG).
• Willingness to travel approximately 50%+ for on-site projects and international assignments.

Responsibilities

• Technical oversight and system ownership for clean utilities (WFI, PW, PS, clean air/nitrogen, etc.).
• Define concepts, specifications, URS, and ensure hygienic design and regulatory compliance.
• Lead clean utility scopes in large CAPEX projects across design, procurement, commissioning and qualification.
• Review and approve engineering deliverables (P&IDs, control philosophies, layouts, automation concepts).
• Coordinate with internal and external partners (EPCMs, OEMs, vendors) to align goals, timelines and risks.
• Act as technical lead for commissioning, qualification, and validation activities (DQ/IQ/OQ/PQ).
• Evaluate and implement new clean utility technologies and digital monitoring tools.

Skills

Clean utilities

GMP compliance

Project management

Stakeholder management

Regulatory knowledge

Education

Bachelor's or Master's in Mechanical/Chemical/Process Engineering

Tools

P&IDs review

Job description

Opportunity

This role is a key part of our Building and Facility Engineering team, dedicated to delivering high-performing clean utility systems critical to pharmaceutical manufacturing. As a member of this team, you will have the opportunity to collaborate closely with internal and external stakeholders to ensure reliable, compliant, and sustainable clean utilities that meet the highest industry standards. Your work will directly contribute to maintaining operational excellence and advancing innovation in pharmaceutical production. As a Senior Project Engineer for Clean Utilities, you will serve as the Subject Matter Expert (SME) and technical authority, owning the end-to-end engineering, execution, and delivery of clean utility systems for complex pharmaceutical manufacturing projects. You will lead engineering efforts to provide state-of-the-art solutions that ensure compliance, sustainability, and operational excellence.

Key duties and responsibilities

• Providing technical oversight and system ownership for clean utility systems such as Water for Injection (WFI), Purified Water (PW), Pure Steam (PS), clean compressed air, clean nitrogen, and process waste systems.
• Defining system concepts, specifications, and URS, ensuring robust hygienic design, material selection, microbial control strategies, and compliance with GMP and regulatory requirements.
• Coordinating and leading clean utility scopes in large CAPEX projects, including concept development, feasibility studies, detailed design, procurement, construction, commissioning, and qualification.
• Reviewing and approving engineering deliverables such as P&IDs, control philosophies, layouts, and automation concepts to meet functionality, quality, and regulatory requirements.
• Managing cross-functional interfaces and external partners, including EPCM firms, OEMs, and equipment suppliers, ensuring alignment on project goals, timelines, and risks.
• Acting as technical lead for commissioning, qualification, and validation activities, including DQ, FAT, SAT, IQ, OQ, and PQ stages in adherence to industry standards like FDA, EMA, and EU Annex 1.
• Leading innovation efforts by evaluating and introducing new clean utility technologies such as membrane-based WFI systems, low-temperature sanitization concepts, energy-efficient generation systems, and digital monitoring tools.

Who You Are

Bachelor's or Master's Degree in Mechanical, Chemical, or Process Engineering, with 5+ years of experience in pharmaceutical, biotechnology, or life science industries. Proven expertise in the design, execution, and validation of clean utility systems, including thermal/membrane WFI generation and distillation technologies. Strong knowledge of European GMP requirements, FDA regulations, and hygienic design principles (ASME BPE, EHEDG). Demonstrated success managing large-scale projects in matrixed environments with diverse stakeholders, including internal teams, EPC partners, and equipment vendors. Willingness to travel extensively (50% +) for on-site project activities, FAT/SAT execution, and international assignments of 1 to 3 years as required.

Salary and Benefits

The expected salary range for this position based on the primary location of North Carolina is $90,600 - $168,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link. This is an on-site position; no remote options are available at this time. Relocation benefits are not approved for this posting.

Location and relocation

Location: North Carolina. This is an on-site position; no remote options are available at this time. Relocation benefits are not approved for this posting.

Equal Opportunity Employer

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

#LI-CA1 #PTTtransformation2026