Senior Project Engineer Clean Utilities

The International Society for Pharmaceutical Engineering, Inc.; Holly Springs (NC); On-site; USD 101,000 - 168,000; Full time

Job summary

The Senior Project Engineer for Clean Utilities will act as SME and technical authority, owning end-to-end engineering, execution, and delivery of clean utility systems for complex pharma manufacturing projects. You will lead efforts to deliver compliant, sustainable solutions with a focus on FDA, EMA, and EU Annex 1 standards.

Responsibilities include defining system concepts, URS, P&IDs, control philosophies, and collaborating with EPCM firms, OEMs, and equipment suppliers to meet project

Qualifications

• Bachelor's or Master's degree in Mechanical, Chemical, or Process Engineering.
• 5+ years in pharma, biotech, or life sciences.
• Expertise in clean utility systems design, execution, and validation.
• Knowledge of European GMP, FDA, and hygienic design (ASME BPE, EHEDG).

Responsibilities

• Provide technical oversight and system ownership for clean utility systems across projects.
• Define concepts, URS, and ensure hygienic design and regulatory compliance.
• Coordinate clean utility scopes from concept to commissioning and qualification.
• Lead commissioning, qualification, and validation activities (DQ, FAT, SAT, IQ, OQ, PQ).

Skills

GMP & regulatory knowledge

Cross-functional collaboration

Project management

Process engineering

Education

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

Job description

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.

The Opportunity

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 include:

• 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.

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.

For questions, please contact Carla Baja, Principal Talent Partner, who is managing this search ([e-mail]).

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