Critical Mass Consulting, LLC · 16 hours ago
Process Engineer - Vacaville, CA
San Francisco, California, United States
Full-time
Hybrid
Mid Level
4+ years expCritical Mass Consulting, LLC is seeking a Process Engineer to join its Vacaville, CA field office, focusing on supporting Life Sciences clients. The role involves leading engineering activities for drug-substance manufacturing and ensuring compliance with design documents and cGMP expectations.
BiotechnologyLife ScienceProject Management
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
Qualification
Required
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)
Preferred
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
Company
Critical Mass Consulting, LLC
A Commissioning, Qualification and Validation Group. Serving Life Sciences partners.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase