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Senior Process Engineer North Carolina
Senior Process Engineer North CarolinaCritical Mass Consulting • Raleigh, NC, US
Senior Process Engineer North Carolina

Senior Process Engineer North Carolina

Critical Mass Consulting • Raleigh, NC, US
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  • [job_card.full_time]
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Job Description

Job Description

Salary :

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 :

  • Process Engineering and Design
  • 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.

Process Engineering Scope

  • Lead and support high-paced engineering activities for complex drug-product manufacturing and equipment readiness programs, including coordination across process systems, equipment vendors, construction partners, and automation teams.
  • Lead and support Tech Transfer and Design of Drug Product (DP) manufacturing systems, including but not limited to : Component sterilization, mixing, Sterile filtration, Aseptic filling, Inspection and testing.
  • Provide day-to-day technical leadership during equipment design, installation, start-up, and commissioning activities, ensuring systems align with design documents, user requirements, and cGMP expectations.
  • 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.
  • Lead proactive vendor management activities to ensure timely deliverables, clear communication, and alignment with project requirements.
  • 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.
  • 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.
  • Support deviation management, vendor document control, and change request workflows to maintain accurate and compliant project documentation.
  • Coordinate closely with automation engineering partners to ensure control system design, installation, and IOQ activities are aligned with equipment requirements and project timelines.
  • 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.
  • Demonstrate strong field presence and ownership, functioning as the clients on-site technical representative throughout installation, commissioning, and qualification.

    • 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
  • 5+ years of Process Engineering or related experience
  • 3+ years experience in Life Sciences GMP environments
  • Excellent written and verbal communication skills, emphasizing strong technicalwriting skills
  • Experience in drugdevice combination product manufacturing and process engineering area is considered a strong plus
  • Experience with large-scale equipment installation, commissioning, automation integration, and vendor coordination within capital project environments is strongly preferred
  • Strong understanding of Good Documentation Practices (GDP), and experience working in FDA regulated industries
  • Ability to perform effective field walk-downs, identify issues, and drive cross-functional resolution quickly and compliantly
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