Senior Project Engineer Clean Utilities

Genentech; Holly Springs (NC); On-site; USD 90,600 - 168,200; Full time

Job summary

A leading biotechnology firm in North Carolina is looking for a candidate to provide technical oversight of clean utility systems essential for pharmaceutical manufacturing. The role involves defining system specifications, leading large-scale projects, and ensuring compliance with regulatory standards. Candidates should have a degree in engineering and relevant experience in the biotech industry. Extensive travel may be necessary. The expected salary range is $90,600 - $168,200, with additional performance-based bonuses.

Qualifications

• 5+ years in pharmaceutical, biotechnology, or life science industries.
• Proven expertise in design, execution, and validation of clean utility systems.
• Willingness to travel extensively (50%+).

Responsibilities

• Provide technical oversight and system ownership for clean utility systems.
• Define system concepts and user requirements, ensuring robust design.
• Coordinate and lead clean utility scopes in large CAPEX projects.

Skills

Technical oversight of clean utility systems

Project management

Knowledge of GMP and FDA regulations

Interpersonal skills with diverse stakeholders

Education

Bachelor's or Master's Degree in Mechanical, Chemical, or Process Engineering

Job description

Overview

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. You will collaborate with internal and external stakeholders to ensure reliable, compliant, and sustainable clean utilities that meet industry standards and support operational excellence and innovation in pharmaceutical production.

Responsibilities

• Provide 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.
• Define system concepts, specifications, and user requirements (URS), ensuring robust hygienic design, material selection, microbial control strategies, and GMP/regulatory compliance.
• Coordinate and lead clean utility scopes in large CAPEX projects, including concept development, feasibility studies, detailed design, procurement, construction, commissioning, and qualification.
• Review and approve engineering deliverables such as P&IDs, control philosophies, layouts, and automation concepts to meet functionality, quality, and regulatory requirements.
• Manage cross‑functional interfaces and external partners, including EPCM firms, OEMs, and equipment suppliers, ensuring alignment on project goals, timelines, and risks.
• Act as technical lead for commissioning, qualification, and validation activities, including DQ, FAT, SAT, IQ, OQ, and PQ in accordance with industry standards (FDA, EMA, EU Annex 1).
• Lead innovation 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.

Qualifications

• Bachelor's or Master's Degree in Mechanical, Chemical, or Process Engineering, with 5+ years in pharmaceutical, biotechnology, or life science industries.
• Proven expertise in 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 (internal teams, EPC partners, 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.

Compensation and Requirements

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 is on‑site with no remote options at this time. Relocation benefits are not approved for this posting.

The position may include benefits as described in company policies. Genentech is an equal opportunity employer. It is our policy to employ, promote, and treat employees and applicants on the basis of merit and qualifications, in compliance with applicable laws. If you require accommodations in the application process, please contact us with the relevant information.

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"Genentech is an equal opportunity employer". This line is retained to reflect policy statements in the original content.