- Job no: 55071GEJP00026139
- Categories: Healthcare
We are looking for a Bioprocess Engineer to work with our Enterprise Solutions Process and System Design (P&SD) team. Do you have a passion for Process Engineering? Then we would love to hear from you. This is a contract opportunity for 12 months and the base location is Marlborough, MA
What you’ll do
- Process Designer will support the process design efforts for biopharmaceuticals, lactoferrin and food products manufacturing, and ensure optimal outcomes to support the customer application and manufacturing operation, in compliance with applicable regulatory requirements. She/he will provide the necessary technical input to support/enable the design and development of the manufacturing suite layouts, process equipment design, process equipment layout, clean utility requirements.
- Process Designer will be responsible for process design documentations and operational estimates such as Basis of Design, Mass/volume Balance, Equipment List, Process Flow Diagrams (PFDs), Production Schedule, Clean Utilities Estimates, Cost of Goods Analysis, Process Definition, etc. Support customer meetings by providing process understanding from pilot scale operation, technology transfer, large scale manufacturing and facility design experience.
- Provide Process Design & Engineering support for the Enterprise Project Team. Work closely with the Enterprise Solutions Project Manager to support the Enterprise Solutions project specific design development, documentation and execution in alignment with the project scope and schedule. Provide design input, support and recommendations as needed with qualification test review and verification and during field execution, commissioning and qualification testing.
- Assure compliance with the Cytiva Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
- Work closely with Customer's Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time. Work closely with Engineering partner companies during Conceptual, Basic design development, installation, commissioning and testing phase to ensure suitability, applicability and accuracy of Engineering partner designs, calculations, drawings; ensure they are in alignment with customer requirements.
- Complete all planned Quality & Compliance training within defined deadlines. Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Work closely with System Designers for the generation of URSs and GSs, and ensure the transfer of critical equipment requirement specification, design meets customer and process needs, and the single-use equipment layout is optimized for the customer facility.
- Approximately 10-30% travel depending on project specifics and geographic location.
Who you are
- BS or MS degree in biochemical / chemical engineering or in a related engineering/life Science discipline or equivalent experience in Biopharma, Lactoferrin and Food industries.
- Minimum of 3 years of relevant bioprocess experience. 1 years of direct experience working in a pilot plant or GMP manufacturing facility.
- Experience in manufacturing of monoclonal antibodies, viral vectors, pDNA and other biologics. Working knowledge of pharmaceutical, Lactoperoxidase / lactoferrin separation, and other biotech processes, equipment hardware, and single use technology. Knowledge of biologics CMC, cGMP manufacturing requirements.
- Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology. Knowledge of biologics CMC, cGMP manufacturing requirements.
- Experience in working with cross functional teams. Experience with Visio, MS Project, SuperPro, and AutoCAD. Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.).
- Disposable technology design and application experience. Detail oriented, excellent at critical analysis and problem solving.
- Comfortable working in global business environment. Structured, Organized, Analytical, Team oriented. Fluent in English both verbally and in writing.
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.
Looking for Meaningful Work? We can help.
If you are a Bioprocess Engineer, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.
We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at email@example.com.
We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.
- Published on 16 Apr 2021, 2:25 PM