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Senior Process Engineer
2 months ago
We are seeking a highly skilled Senior Process Engineer to join our team at Trinity Consultants - Advent Engineering. As a key member of our engineering team, you will be responsible for designing, developing, and implementing process engineering solutions for our clients in the biotechnology and pharmaceutical industries.
Key Responsibilities- Lead and/or participate in client meetings to discuss technical issues, project updates, and project progress.
- Interact with project management, vendors, and clients in coordination, design, review, start-up, and commissioning of biopharmaceutical processes, facilities, and utilities systems.
- Generate and review engineering design specifications, documentation, and drawings for upstream, downstream bulk processing equipment and critical utilities.
- 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 (PFDs), process and instrumentation diagrams (P&IDs), data sheets, sizing, and preparing specifications 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 RFIs, submittals, responding to design change notices, issuing field change bulletins, attending site walk-throughs, and issuing field observation reports.
- 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.
- Requires a bachelor's or master's degree in Mechanical Engineering, Chemical Engineering, Biochemical Engineering, or related discipline.
- Ten (10) 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 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.
**Note:** This position is not open to working with 3rd party vendors/C2C.
