Atika Technologies
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.