• Degree in Mechanical, Chemical Engineering or equivalent with 5-7 years of relevant experience in a cGMP setting.
• Minimum of 5-7 years experience in the Pharmaceutical or Biotechnology industry Knowledge and experience in a production area (e.g. cell culture, microbial fermentation, buffer prep, media prep, purification, etc.).
• At least 2-3 years of project experience or similar leadership role in industry is required.
• Experience working on Large Capital Projects
• Demonstrable experience working to standards required for regulatory compliance of Aseptic Processing facilities.
- Broad understanding of engineering and process knowledge associated with various sterilization technologies, GXP utilities and associated pharmaceutical processes.
• Proficient at assembling project budgets.
• Familiarity with PLCs, DeltaV and BAS is a plus
• Capable to manage a project utilizing project management tools such as MS Project, etc.
• Demonstrates a proficient understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems.
• Capable of performing risk assessments
• Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for complex equipment or systems
In-depth understanding and knowledge of Cell Culture and/or Purification; Including but not limited to Bioreactor systems, centrifuges, CIP Skids, chromatography system operation, column performance and UF skid operation-
The engineering group provides technical engineering and project management services for biopharm manufacturing operations, building and utility equipment, validation and capital projects.. As a Process Engineer, you will work as part of a multi-functional team in order to ensure the on-time delivery of a $143M project to support the internal expansion of biopharm manufacturing capacity at the Global Manufacturing & Supply (GMS) Rockville site. You will also maintain a compliant and safe manufacturing environment, and help to ensure a consistent supply of product to the customer. The individual will be responsible for engineering support of manufacturing operations across all cGMP biologics production facilities
• Ability to demonstrate use of problem solving and continuous improvement techniques.
• Good verbal and written communication skills.
• Ability to work effectively both on your own initiative and as part of a team.
• Understanding of Regulatory, Technical & Safety Standards.
• Capable of supervising the activities of contractors.
• Capable of maintaining system life cycle documentation (Drawings, Design Files, FRS, SDDS, etc).
• Understands and applies basic engineering principles to equipment, instrumentation, and materials of construction to troubleshoot equipment or system related problems.
• Proficient at producing detailed engineering reports that provide viable and cost effective alternatives for equipment or systems of minimal to moderate design.
• Strong planning & organisational skills (and an ability to work to targets and deadlines).
• Ability to lead FAT/SAT and commissioning of complex systems
• Ability to travel up to 25%
You may apply for this position online by selecting the Apply now button.
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