Senior Process Engineer - Philadelphia

Critical Mass Consulting, LLC is seeking individuals who want to learn and develop within a dynamic, start-up environment. We believe in our purpose : To develop a company which thrives on connectivity and engagement; to build a premier consulting organization, which rewards creativity, contribution, and growth.

Critical Mass Consulting, LLC is supporting Life Sciences clients in the areas of :

• Project Management
• Equipment, Utility and Facility Start-Up and Commissioning / Qualification
• Validation Program Development
• Tech Transfer, Process Engineering and Validation

Cleaning / Sterilization Validation

Our company places an emphasis on continuous personal development. This includes support / financing of technical training, mentorship, and development of high performance teams.

Job Description :

Critical Mass Consulting, LLC is recruiting a Senior Process Engineer supporting Life Sciences clients in Philadelphia, PA. If you have a passion for Life Sciences and helping others, we are interested in discussing our company, our process and what it means to join our team-focused organization.

This role requires full on-site support in the Philadelphia area, ensuring timely engagement, responsiveness, and hands-on leadership for manufacturing operations, qualifications, and tech transfer activities.

System procurement and vendor coordination

Generation and review of Validation Master Plan documentation (URS, FRS, Design Qualification) for standard equipment and custom-built systems

Project Management Responsibilities

Provide status updates, risk identification, and mitigation strategies to leadership and stakeholders in a timely manner.

Coordinate resources, vendors, and cross-functional teams to ensure projects are executed on time, within scope, and in compliance with quality standards.

General Consulting Responsibilities

Required Qualifications

People Come First

Experience in drug-device combination product manufacturing and process engineering area is considered a strong plus

Strong understanding of Good Documentation Practices (GDP), and experience working in FDA regulated industries