Process Engineer

Please note:
We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company 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, facility/system design, 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 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!

The Sr. Process Engineer will be the Subject Matter Expert (SME) and build, direct a group of engineers in the design and implementation of process equipment, automation, commissioning and support start-up of various pharmaceutical manufacturing equipment. A combination of strong technical aptitude, engineering skills and technical writing are the desired skill set. This role involves managing projects, developing process designs, and ensuring compliance with GMP, FDA, and industry standards.

The leader for this discipline is capable of leading by example and responsible for executing both engineering projects as well as facilitating the growth of the discipline.

• Incumbent must have knowledge and experience in:
• Designing and engineering principles related to sanitary/ hygienic application for the biopharmaceutical and pharmaceutical industry
• Generation and review of engineering design specifications, documentation, and drawings for upstream, downstream bulk processing equipment (bioreactors/fermenters, chromatography skids, 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.), CIP systems, and equipment used in Single Use application (e.g., SUBs, SUM, etc.)
• Regulatory guidelines, industry best practices, and standards that steer the industry (e.g., FDA, EU GMP, ICH, USP, ISPE, ASME BPE, PDA, ISO, etc.)
• Review calculations of loads and sizing of equipment, layout of systems, develop and review specifications, prepare design drawings, and coordinate process system interfaces
• Review process flow diagrams (PFD’s), process and instrumentation diagrams (P&’s), data sheets, sizing and preparing specifications for equipment, instruments, and utilities used in a GMP environment.
• 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 issue field observation reports, developing operational and functional acceptance tests, develop drawings, and produce 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.
• Establish and maintain excellent working relationships with clients and members of the design team.
• Technical documentations and specifications (e.g., equipment specifications, datasheets, URS, functional specifications, turnover package, etc.)
• Experience in Process Automation to support control narrative and sequences
• Experience with managing analytical lab equipment upgrades projects.
• Experience in piping design and layout best practices in hygienic application
• Participate in design reviews, HAZOPs, and constructability reviews to ensure quality and safety.
• Manage and resolve design changes and field issues during construction.
• Work closely with clients and stakeholders to gather requirements and present technical solutions.
• Ensure alignment of piping designs with project objectives, timelines, and budget constraints.
• Familiar on utilizing and/or reviewing hydraulic simulation model software e.g., Pipe Flo.
• Define process equipment user requirements and collaborate with vendors on design/specification.
• Support FAT/SAT, commissioning, qualification (IQ/OQ), and integration of process systems.

Directly supervise a number of Process, technical/CQV team members during Design, Commissioning and Qualification phase of the project.

To perform this job successfully, an individual must be able to perform each essential duty…