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Critical Mass Consulting, LLC · 4 months ago

Senior Process Engineer – North Carolina

Raleigh, North Carolina, United States

Full-time

Onsite

Senior Level

6+ years exp

Critical Mass Consulting, LLC is seeking a Senior Process Engineer to join its North Carolina field office, focusing on supporting Life Sciences clients. The role involves leading tech transfer and process engineering activities, managing system lifecycle processes, and providing mentorship to junior engineers.

BiotechnologyLife ScienceProject Management

Responsibilities

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

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

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

Process EngineeringTech TransferValidation Master PlanDrug-Device CombinationDocumentation PracticesTechnical WritingProject ManagementCommunication Skills

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

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