SUMMARY
The Process Engineer will participate with a group of engineers in the design and implementation of process equipment, automation, commissioning, and support start-up of various manufacturing equipment used in life science industry. A combination of strong technical aptitude, engineering skills, and technical writing is the desired skill set. This role involves managing projects, developing process designs, and ensuring compliance with GMP, FDA, and industry standards. The role participates in the creation of P&IDs, specifications, URS, and protocols while coordinating with cross-functional teams. Strong proficiency in AutoCAD and familiarity with ASME B31.3 and ASME BPE, and B&PV codes are essential.
DUTIES AND RESPONSIBILITIES:
- Interact with project management, vendors, and clients in coordination, design, review, start-up and CQV of biopharmaceutical process, facilities/utilities systems, and process equipment
- Generation and review of engineering design specifications, documentation, and drawings for upstream, downstream bulk processing equipment (bioreactors/fermenters, chromatography skids, bioreactors, TFF, UFDF, centrifuge etc.), solid/ oral dosage equipment (tablet press, powder compactors, coating pans, compounding skids for mixing, etc.), critical utilities (WFI, process gases, pure steam, etc.), FFIP (formulation equipment, isolators, fillers, lyophilizer, etc.), and/or equipment used in Single Use application (e.g., SUBs, SUM, etc.)
- Develop calculations of loads and sizing of equipment, layout of systems, develop and review specifications, prepare design drawings, and coordinate process system interfaces
- Develop process flow diagrams (PFDs), process and instrumentation diagrams (P&IDs), data sheets, and sizing and preparing specifications for equipment, instruments, and utilities used in a GMP environment
- Ability to review and interpret vendor drawings, datasheets, equipment packages, P&IDs, utility requirements, and technical submittals.
- Participate in construction activities as needed, including reviewing RFI’s, submittals, responding to design change notices, issuing field change bulletins, attending site walk-throughs and issuing field observation reports, developing operational and functional acceptance tests, developing drawings, and producing other system documentation
- 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.
REQUIRED SKILLS/ABILITIES:
- General working experience in process automation to support control narrative and sequences
- General working experience in piping design and layout, best practices in hygienic application
- Familiarity in process instrumentation and components for hygienic application
- Familiarity with GMP design principles, ASME BPE standard and ASME B31.3 and B&PV code
- Participate in design reviews or other risk reviews where required
- Work closely with clients and stakeholders to gather requirements and present technical solutions
- Conduct quality control checks on design deliverables to ensure consistency and accuracy
- Familiar with utilizing Autocad Plant 3D
- Strong written and verbal communication skills and ability to coordinate effectively with clients, vendors, and multidisciplinary engineering teams.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree (B.S.) in Life Science related field from a four-year college or university or foreign equivalent; and at least 3 years related experience
- A minimum of 3 years of relevant process engineering experience within the Life Science sector
- Ability to travel to project and manufacturing sites for at least 50% of the time or as required
- Must have computer literacy, including word processing, spreadsheet skills, and knowledge of Microsoft Office software package and AutoCAD.
- Familiarity with Revit, Navisworks, PIPE-FLO, or other 3D coordination/process calculation software is an asset
- Previous experience in an engineering consulting or EPCM environment would be an asset
