Senior Process Engineer Philadelphia
hace 8 días
Philadelphia
Job DescriptionSalary: 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, • 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 supporting Life Sciences clients in Philadelphia, PA. 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 Philadelphia 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, • 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 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 technicalwriting skills