Process Engineer - Vacaville, CA

Critical Mass Consulting•San Francisco, CA

18d•Onsite

About The Position

Critical Mass Consulting, LLC is recruiting a Process Engineer to join its Vacaville, CA 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-substance 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 Purification manufacturing systems. 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. 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.

Requirements

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
4+ years of relevant engineering experience in the Life Sciences industries.
A passion for Life Sciences and helping others.
Excellent written and verbal communication skills.
Strong competency in using Project Management tools.
Proficient in Microsoft Office Suite (MS Word and MS Excel).

Nice To Haves

Experience with plant shutdown projects
Experience with commissioning and/or decommissioning of process equipment and utility systems
Experience with upstream and downstream process equipment
4-8 years of experience Project experience in pharmaceutical, medical device or biotech industry.

Responsibilities

Lead and support high-paced engineering activities for complex drug-substance 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 Purification manufacturing systems.
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.
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.