Senior Clean Utilities Engineer – Pharma Manufacturing

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

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