What are the responsibilities and job description for the Process Engineer position at Steneral Consulting?
Onsite role, must be local
need only 1 strong candidate
Bachelor's Degree in Chemical Engineering (or other related field) with 0-2 years of experience (or equivalent combination of education and experience) in the design and construction of processing equipment and instrumentation in a manufacturing plant environment in the biotechnology or pharmaceutical industries.
This Process Engineer position will have an area of focus on equipment functionality and operational requirements in a specific process flow, as well the design, optimization, and implementation of Manufacturing and GxP Laboratory equipment. This position reports directly to the Manager of Process Engineering and will work closely with all members of the Engineering, Quality, IT, Validation, Facilities, Lab Operations, and the Manufacturing Operations groups to meet user requirements and optimal function of all Manufacturing, Laboratory and Building Space criteria.
Essential Functions
need only 1 strong candidate
Bachelor's Degree in Chemical Engineering (or other related field) with 0-2 years of experience (or equivalent combination of education and experience) in the design and construction of processing equipment and instrumentation in a manufacturing plant environment in the biotechnology or pharmaceutical industries.
This Process Engineer position will have an area of focus on equipment functionality and operational requirements in a specific process flow, as well the design, optimization, and implementation of Manufacturing and GxP Laboratory equipment. This position reports directly to the Manager of Process Engineering and will work closely with all members of the Engineering, Quality, IT, Validation, Facilities, Lab Operations, and the Manufacturing Operations groups to meet user requirements and optimal function of all Manufacturing, Laboratory and Building Space criteria.
Essential Functions
- Responsible for creating and maintaining Process Flow Diagrams, Risk Assessments, Asset Standardization, and Master Specification Sheets.
- Support the evaluation, selection, and recommendation of process and laboratory equipment that meet quality/regulatory compliance for Phase 1 and 2 Clinical Manufacturing of Drug Substance and Drug Product.
- Responsible for creating and maintain OEM Files which include Equipment Turnover Packages, O&M Manuals, and Drawings.
- Be able to perform and deliver specific engineering project tasks as necessary.
- Represent the F&E team during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.
- Perform Front-End Loading (FEL) and feasibility studies of equipment used in both GMP and cGLP applications.
- Responsible for process troubleshooting during startup of new and existing facilities and process/laboratory equipment.
- Responsible for analysis and upgrade of process and utility systems as needed. Example of utility systems include: Autoclaves, WFI, RODI, HVAC, CCA, and steam generation. Example of process systems include both Upstream (Bioreactors, Incubators, and others), Downstream (Centrifugation, Chromatography, Filtration), and supporting lab equipment (Temperature control units, Cell counters, HPLC’s, etc).
- Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
- Ensure that all appropriate documentation, drawings specifications are generated in compliance with procedures and statutory requirements (US FDA and ISO).
- Responsible for the development of P&ID’s and Process Flow Diagrams.
- Provide technical input for analysis of process changes.
- Support the evaluation, selection, and recommendation of process and laboratory equipment that meet quality/regulatory compliance for Phase 1 and 2 Clinical Manufacturing of Drug Substance and Drug Product.
- Responsible for creating and maintain OEM Files which include Equipment Turnover Packages, O&M Manuals, and Drawings.
- Be able to perform and deliver specific engineering project tasks as necessary.
- Represent the F&E team during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.
- Perform Front-End Loading (FEL) and feasibility studies of equipment used in both GMP and cGLP applications.
- Responsible for process troubleshooting during startup of new and existing facilities and process/laboratory equipment.
- Responsible for analysis and upgrade of process and utility systems as needed. Example of utility systems include: Autoclaves, WFI, RODI, HVAC, CCA, and steam generation. Example of process systems include both Upstream (Bioreactors, Incubators, and others), Downstream (Centrifugation, Chromatography, Filtration), and supporting lab equipment (Temperature control units, Cell counters, HPLC’s, etc).
- Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
- Ensure that all appropriate documentation, drawings specifications are generated in compliance with procedures and statutory requirements (US FDA and ISO).
- Responsible for the development of P&ID’s and Process Flow Diagrams.
- Provide technical input for analysis of process changes.
- Bachelor's Degree in Chemical Engineering (or other related field) with 0-2 years of experience (or equivalent combination of education and experience) in the design and construction of processing equipment and instrumentation in a manufacturing plant environment in the biotechnology or pharmaceutical industries.
- Bachelor's Degree in Chemical Engineering (or other related field) with 0-2 years of experience (or equivalent combination of education and experience) in the design and construction of processing equipment and instrumentation in a manufacturing plant environment, preferably in the biotechnology or pharmaceutical industries.
