Senior Process Engineer – North Carolina

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 to join its North Carolina field office. 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 Raleigh Durham North Carolina 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