Process Engineer

Process Engineer (Biotech)

ADVENT Engineering Life Science Solutions, a Trinity Consulting Co., is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Located near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, ADVENT is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning & qualification and start-up of various processes, systems, and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set. This is an outstanding opportunity to join our growing team!

Responsibilities

• Lead and/or participate in client meetings to discuss technical issues, project updates, project progress.
• Interact with project management, vendors and clients in coordination, design, review, start-up and CQV of biopharmaceutical process, facilities/utilities systems and FFP equipment
• Generation and review of engineering design specifications, documentation, and drawings for upstream, downstream bulk processing equipment (fermenters, chromatography skids, bioreactors, TFF, UFDF, centrifuge etc.) and critical utilities (WFI, process gases etc.)
• Responsible for the design review to ensure the design is consistent with industry-accepted and best practice, leading edge technologies and client requirements
• Develop calculations of loads and sizing of equipment, layout of systems, develop and review specifications, prepare design drawings, and coordinate process system interfaces
• Develop and/or review process flow diagrams (PFD’s), process and instrumentation diagrams (P&ID’s), data sheets, sizing and preparing specification for equipment, instruments, and utilities used in a GMP environment.
• Excellent understanding of applicable industry codes and standard practices (e.g., ASME BPE, etc.)
• Complete process engineering studies, reports, and calculations
• Regularly collaborate with senior management and counterparts with respect to technology advancements, lessons learned, design techniques
• Participate in construction activities as needed, including reviewing RFI’s, submittals, responding to design change notices, issuing field change bulletins, attend site walk-throughs and issue field observation reports, develop operational and functional acceptance tests, develop drawings, and produce other system documentation
• Perform fluid flow and pressure modeling using advanced modeling systems
• Estimate utility requirements for new manufacturing processes, design utilities generation and distribution systems.
• Perform engineering studies for expanding, improving or automating existing facilities with limited supervision.
• Assume ownership of the process-related aspects of a portion of a large project or an entire small project and provide technical support to the design team.
• Establish and maintain excellent working relationships with clients and members of the design team.
• Must be able to demonstrate ability to work in a leadership role and work independently

Qualifications

• Requires a bachelor’s or master’s degree in Mechanical Engineering, Chemical Engineering, Biochemical Engineering, or related discipline. Engineering degree is preferred.
• Five (5) plus years of experience in the biotech-pharmaceutical environment.
• Basic knowledge of upstream/downstream drug substance manufacturing, fill/finish and packaging, and bulk processing equipment including utilities (WFI, CO2 etc.).
• Basic knowledge of the Commissioning and Qualification.
• Direct experience in the design or commissioning/qualification in any of the following systems: upstream / downstream bulk process equipment, lyophilization, formulation / fill vial and syringe forms, sterilization, Clean-In-Place, clean utilities (WFI/PW, Pure Steam, Clean Gases).
• Strong knowledge on review, understanding P&IDs drawings, ISA symbology is important
• Strong knowledge of hygienic process components, instruments is required
• Basic knowledge of automation narratives and architecture of various platforms, including PLC/SCADA, DCS (e.g., DeltaV) and BMS/BAS experience is a plus.
• Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus.
• Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, SharePoint, etc. in addition to experience working within shared work environments.
• Travel within USA as needed for the projects.

Seniority Level

• Intermediate