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
• Computerized System Validation (CSV)

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.

• Lead and support high-paced Tech Transfer/process engineering of the Drug Product (DP) manufacturing unit operations, including but not limited to: Component sterilization, mixing, Sterile filtration, Aseptic filling, Inspection and testing
• Manage and support process engineering and system lifecycle activities, including:
  System procurement and vendor coordination
  • Generation and review of Validation Master Plan documentation (URS, FRS, Design Qualification) for standard equipment and custom-built systems
  • FAT/SAT, IOQ/PQ execution and oversight
• Support system receipt verifications, automation loop testing, equipment startup, facility and utilities readiness, and mechanical completion activities, ensuring proper commissioning, testing, and hand-over to end users
• Serve as the technical representative of the process engineering team, supporting project manager(s) and providing on-site expertise during critical phases of execution.
• Conduct a thorough review of P&ID and electrical schematics and perform walk-downs, identify gaps or issues, and drive collaborative resolution in a timely and compliant manner
• Provide on-the-floor troubleshooting and SME level support for systems and processes, ensuring timely resolution of issues through collaboration with internal teams, vendors, and external stakeholders.
• Review and verify the accuracy of Turnover Packages (TOPs) in alignment with approved SOPs and cGMP requirements.
• Track and document issues in an organized, transparent manner to provide visibility to project stakeholders and drive timely closure.
• Work independently while maintaining constant collaboration with cross-functional teams, ensuring smooth project execution and technical alignment.
• Manage and oversee document workflows within paperless validation/documentation systems. Experience with VEEVA or Master control, paperless validation systems such as Kneat or ValGenesis is a strong plus.
• Provide mentorship and training to junior engineers, sharing technical expertise, best practices, and guidance to strengthen team capabilities and ensure consistent project execution standards.

Project Management Responsibilities

• Partner with project managers to develop and track project timelines, deliverables, and milestones, ensuring alignment with overall program objectives.
  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

• Build and maintain strong, trust-based relationships with clients, acting as a reliable SME and strategic partner throughout project execution.
• Demonstrate dynamic problem-solving and critical thinking skills to provide clients with practical, risk-based solutions that balance compliance, efficiency, and innovation.

Required Qualifications

• Belief in our Core Values. These 4 values provide the foundation for how we operate as a company. With these common shared values, we can effectively accomplish our mission of organizational excellence.
  • People Come First
  • We Build Together
  • Empowering Growth and Leading People to Make a Difference
  • Joy and Discipline, Life in Balance
• Strong interest in Life Sciences and a passion for helping others
• Excellent written and verbal communication skills, emphasizing strong technical writing skills
• Minimum 6 years of technical experience working in equipment and/or process engineering roles within the pharmaceutical, medical device or biotech industry
  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