Process Engineer
Apply NowCompany: Atika Technologies
Location: Frederick, MD 21705
Description:
Role: Process Engineer
Location: Fredericksburg, MD (onsite)
Visa: ny visa apart from H1
Duration: 12+ month
Process Engineering is responsible for providing technical support to the manufacturing and logistics buildings for troubleshooting, modifications and improvements related to process, clean-in-place, steam-in-place, washing, and sterilizing equipment systems.
Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).
Knowledge of the product flow through the various production areas.
Basic understanding of PLC and distributed control systems, HMIs, and data historians.
Familiar with the operation and maintenance of process equipment in either production area:
Basic understanding of engineering principles (fluid dynamics, heat transfer, etc.) and how they are applied to the operation of the production equipment.
Familiar with the cleaning and sterilization strategy for process vessels and transfer lines.
bility to use process data (i.e., temperatures, pressures, valve sequencing, etc.) to solve equipment-related issues.
Familiar with regulatory audit process and capable of gathering supporting documents
o Upstream equipment:
Incubators
Bioreactors
Centrifuges
Pasteurizer
o Downstream equipment:
Chromatography columns
Viral inactivation
Ultrafiltration
Diafiltration
Freeze/thaw
Engineer's Core Responsibilities:
Scope
Select, design, and implement new/replacement systems as required for existing or new (tech transfer) processes, equipment, and automated systems; continuous improvement initiatives; and Asset Life Cycle Management.
Resolve technical issues, identifying root causes and defining corrective/preventive actions with equipment and automated systems.
Lead assigned change controls associated with equipment and automated systems.
Possess some technical skills and knowledge with biopharmaceutical operations, process/utility equipment, and automated systems.
Create/update equipment and automated systems operation and maintenance documentation and training materials.
Identify/update spare parts and preventive maintenance procedures for new/modified equipment and automated systems.
Support FAT, SAT, commissioning, and validation activities for assigned equipment and automated systems.
Projects/Activities
Efficiently and effectively manage assigned projects and initiatives.
s required by group, assist Senior and Principle Engineers on more complex projects/initiatives.
Manage of internal and external resources for assigned projects/initiatives.
Contribute to functional and departmental development and Lean initiatives.
Knowledge
Fundamental understanding of biopharmaceutical processes and equipment through coursework or previous work experience.
Develop an understanding of equipment, processes, and automated system design through coaching and support.
Familiarity with common business systems and processes.
Understanding of Lean concepts and waste reduction.
Develop understanding of GMP requirements and engineering fundamentals.
Effective working knowledge and experience relevant to at least one technical discipline and/or therapeutic area.
Location: Fredericksburg, MD (onsite)
Visa: ny visa apart from H1
Duration: 12+ month
Process Engineering is responsible for providing technical support to the manufacturing and logistics buildings for troubleshooting, modifications and improvements related to process, clean-in-place, steam-in-place, washing, and sterilizing equipment systems.
Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).
Knowledge of the product flow through the various production areas.
Basic understanding of PLC and distributed control systems, HMIs, and data historians.
Familiar with the operation and maintenance of process equipment in either production area:
Basic understanding of engineering principles (fluid dynamics, heat transfer, etc.) and how they are applied to the operation of the production equipment.
Familiar with the cleaning and sterilization strategy for process vessels and transfer lines.
bility to use process data (i.e., temperatures, pressures, valve sequencing, etc.) to solve equipment-related issues.
Familiar with regulatory audit process and capable of gathering supporting documents
o Upstream equipment:
Incubators
Bioreactors
Centrifuges
Pasteurizer
o Downstream equipment:
Chromatography columns
Viral inactivation
Ultrafiltration
Diafiltration
Freeze/thaw
Engineer's Core Responsibilities:
Scope
Select, design, and implement new/replacement systems as required for existing or new (tech transfer) processes, equipment, and automated systems; continuous improvement initiatives; and Asset Life Cycle Management.
Resolve technical issues, identifying root causes and defining corrective/preventive actions with equipment and automated systems.
Lead assigned change controls associated with equipment and automated systems.
Possess some technical skills and knowledge with biopharmaceutical operations, process/utility equipment, and automated systems.
Create/update equipment and automated systems operation and maintenance documentation and training materials.
Identify/update spare parts and preventive maintenance procedures for new/modified equipment and automated systems.
Support FAT, SAT, commissioning, and validation activities for assigned equipment and automated systems.
Projects/Activities
Efficiently and effectively manage assigned projects and initiatives.
s required by group, assist Senior and Principle Engineers on more complex projects/initiatives.
Manage of internal and external resources for assigned projects/initiatives.
Contribute to functional and departmental development and Lean initiatives.
Knowledge
Fundamental understanding of biopharmaceutical processes and equipment through coursework or previous work experience.
Develop an understanding of equipment, processes, and automated system design through coaching and support.
Familiarity with common business systems and processes.
Understanding of Lean concepts and waste reduction.
Develop understanding of GMP requirements and engineering fundamentals.
Effective working knowledge and experience relevant to at least one technical discipline and/or therapeutic area.