Hughes Engineering & Consulting is an exciting, fast growing company focused on process engineering and project management for the pharmaceutical industry. We offer great benefits, and exciting challenges for both career development as well as personal leadership development any many group social activities!Job Description
Hughes Engineering & Consulting is seeking qualified, Senior Process Engineers with specific experience in Biotechnology including upstream cell culture fermentation, centrifuge harvesting, as well as downstream purification unit operations such as UF/DF, Chromatography, Ultracentrifugation.
The successful candidate will support multi-year projects; starting with conceptual scope and funding package development, detail design, equipment and facility construction and integration, startup and commissioning and will oversee the project through validation and operational readiness. Candidates should have prior experience in cGMP capital projects.
Knowledge in automation, PLC/DCS systems a plus but not required. Specific experience on large capital projects is also a plus. This project will be a rewarding experience for the successful candidate.
Specific Job Duties:
Ability to work remotely and attend video-based meetings supporting a global client. Meetings may occur after normal working hours for the EST time zone.
Determines/Develops project specifications by studying product design, customer requirements and performance standards; completing technical studies; preparing cost estimates.
Determine/develop together with other stakeholders the change scope and strategy to execute the change in a cGMP environment, process equipment, utilities, facility modification requirements to meet regulatory expectations and client quality standards for aseptic production environment.
Coordinate with site departments such as MS&T, Engineering, Automation, Quality and Manufacturing to develop the scale up and basis of design for the project.
Work with third party engineering firms to develop overall project basis of design and conceptual scope documents.
Coordinate the selection and oversight of third-party engineering and design services.
Coordinate the specification and procurement of process equipment and facility construction services.
Coordinate with internal and external stakeholders through all phases of the project.
Coordinate during the construction phase, the review and approval of submittals on process, facilities and utilities.
Coordinate with startup teams during the turnover, startup and commissioning phases for process and utilities.
Project life-cycle documentation requirements as required for a cGMP compliant project (URS, change management, system specifications, etc.)
Assist the CQV team with developing commissioning, validation strategies and plans; identify strategic objectives to bring the facility up to operational readiness.
Work with site Quality, Validation, Manufacturing groups to harmonize goals and objectives, strategies to achieve operational readiness.
Provide oversight for the development of cleaning programs, cleaning validation and SIP/CIP cycle development.
Minimum 8 years of relevant industry experience (SME level)
Cell Culture/Fermentation, Harvesting and Purification Unit Operations in cGMP manufacturing
Detail Design Engineering Experience
Skills/Qualifications: Organized Mindset, Analytical Decision-Making, Requirements Analysis, Design Skills, Project Management, Manufacturing Methods and Procedures, Process Improvement, Technical Understanding, Documentation Skills, Safety Management, Supervision, CAD, Process/Project Engineering.
**Hughes Engineering, PLLC is an equal opportunity employer**