Project Engineer – GMP Manufacturing

Job Title: Project Engineer – GMP Manufacturing

Location: Boston/Cambridge, MA

Duration: 12 Months (Potential Extension up to 2 Years)

Position Overview

We are seeking an experienced Project/Site Engineer to provide engineering support for GMP manufacturing operations within a regulated pharmaceutical/biotechnology environment. The successful candidate will support facility and utility systems, commissioning and qualification activities, change management, and continuous improvement initiatives while ensuring compliance with FDA, cGMP, and industry standards.

Key Responsibilities

• Provide day-to-day engineering support for facilities, utilities, and manufacturing systems in a GMP environment.
• Support the operation, maintenance, and troubleshooting of critical utility systems, including HVAC, Clean Steam, Water for Injection (WFI), Compressed Gases, Process Piping, and Controlled Environment Utilities.
• Author, execute, and manage change controls within the Quality Management System (QMS).
• Support commissioning, qualification, and validation activities, including FAT, SAT, IQ, OQ, and PQ.
• Review, update, and develop engineering documentation, including P&IDs, equipment specifications, as-built drawings, and redline markups.
• Participate in deviation investigations and support CAPA development and implementation.
• Assist with regulatory inspection readiness and support internal and external audits.
• Provide technical oversight for architectural and engineering firms, equipment vendors, and subcontractors.
• Troubleshoot equipment and facility issues and support planned maintenance shutdown activities.
• Participate in engineering meetings, work order management, and continuous improvement initiatives.
• Maintain accurate GMP documentation in accordance with regulatory and company requirements.

Required Qualifications

Education

• Bachelor's degree in Chemical, Mechanical, Electrical, or a related Engineering discipline.

Experience

• Minimum of 5 years of engineering experience in pharmaceutical, biotechnology, biopharmaceutical, or oral solid dose manufacturing within a GMP-regulated environment.
• Demonstrated experience supporting GMP facility and utility systems, including HVAC, WFI, Clean Steam, CIP/SIP Systems, and Environmental Monitoring Systems.
• Hands-on experience with Commissioning, Qualification, and Validation (CQV) lifecycle documentation, including URS, Functional Specifications, FAT/SAT, IQ/OQ/PQ, Impact Assessments, and Traceability Matrices.
• Direct experience authoring and executing change controls in a regulated quality system.
• Knowledge of cleanroom classifications, including ISO 8, ISO 7, ISO 5, and Grade D/C/B/A environments.
• Working knowledge of Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and SCADA platforms.
• Experience with CMMS platforms such as Maximo, Blue Mountain, or equivalent.
• Ability to qualify for and work within aseptic manufacturing environments.
• Strong understanding of cGMP documentation practices and regulatory compliance requirements.
• Excellent troubleshooting, communication, and organizational skills.

Preferred Qualifications

• Experience in Cell & Gene Therapy, aseptic fill-finish, or advanced therapy manufacturing environments.
• Experience supporting FDA and/or EMA inspections.
• Familiarity with ISPE Baseline Guides related to Commissioning & Qualification, Facilities & Equipment, and Water & Steam Systems.
• Experience with electronic validation management systems such as Kneat, ValGenesis, or equivalent.
• Knowledge of ISPE GAMP, 21 CFR Part 11, EU Annex 11, and Computer Software Assurance (CSA) methodologies.
• Previous experience working in a consulting or embedded engineering support model.