Process Engineer / Senior Process Engineer 

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 API manufacturing equipment

·Generation and review of engineering design specifications, documentation, and drawings for bulk processing equipment

·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 and piping, 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 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

·Estimate utility requirements for new manufacturing processes, design utilities generation and distribution systems.

·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.

·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 plus years of experience in the biotech, pharmaceutical, or industrial environment.

·Basic knowledge of chemical, API or biopharmaceutical manufacturing, packaging, and bulk processing equipment

·Basic knowledge of Commissioning, Qualification and Validation Process.

·Direct experience in the design or commissioning/qualification in any of the following systems: bulk process equipment, formulation equipment, filling, inspection, and packaging lines, and/or utilities.

·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.