Offered Salary 1000
Experience 5 Years
Qualifications Degree Bachelor
This position will drive a Pall Advanced System Solutions (PASS) team to deliver custom and standard bioprocessing equipment solutions across the biotechnology product catalog, with a focus on Single-use mixing technology. Through the analysis of the customer’s processes and user requirements, this individual will work within a project team to assess and define engineered system solutions with the customer, provide critical technical information for the proposal, and execute & test the engineered solution based on defined contractual specifications. As well as direct customer project work, the position will involve working on internal NPD (New Product Development) and sustainment activities.
This role works closely with project managers and other functions to ensure engineering solutions meet customer requirements, project schedule, and budget.
In the role, it is encouraged that the senior engineer is able to drive both customer and internal NPD & sustainment projects to completion.
Essential Job Functions:
- Communicates cross functionally on progress monitoring, reporting, presentations and coordination of sub supplier activities (e.g. mechanical fabricators, electrical fabricators and software companies).
- Participate in Continuous improvement processes and execute daily visual management.
- Enter time into SAP and ensure updates are maintained.
- Support testing activities both domestically and internationally for Biopharma systems in accordance with key-performance-indicators: according to specification, on time and within budget.
- To work safely and to align with the company’s health, safety and environmental (HSE) policies and procedures.
- Communicate optimally on technical / engineering issues internally as well as with the customer.
- Solving problems of automated system components to identify root-cause of items identified during execution.
- Working in multidisciplinary team (manufacturing, quality, engineering, R&D, commercial, others) to investigate issues found, as well as optimize products to prevent re-occurrence in the future.
- Provides conceptual and detailed designs using 3D CAD software (SolidWorks/Inventor). Uses tolerance analysis and stress calculations for design analysis.
- Evaluates technical risks by leading DFMEA’s and ensuring accurate completion of required actions.
- Helps develop project plans, stage gate deliverables, conducts design reviews, and anticipates project roadblocks, delays and risks. Utilizes critical issue and communication techniques to problem solve.
- Bachelor’s degree in Chemical/Mechanical/Biomedical Engineering or related field.
- 5+ years of experience in an engineering role in a related field.
- Knowledge of Biotech Processes and of the Biotech market.
- Understanding of mixing principles and applications (buffer management, slurry vessels).
- Understanding of filtration separation and purification technologies used in the downstream processing (Direct flow filtration, tangential flow filtration, chromatography) (asset, but not required).
- Knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and detailing biopharmaceutical process equipment. (ASME BPE, GAMP, cGMP, Validation, IQ/OQ, Commissioning, SAT, FAT, SOPs, OSHA, ISPE, etc.)
- Computer skills relating to general usage (Windows, Outlook, MS Office, etc.)