Process Engineer - 237707 - Medix™ : Job Details

Familiar with the operation and maintenance of process equipment in either production area:

Upstream equipment:

• Incubators
• Bioreactors
• Centrifuges
• Pasteurizer
• 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.

Possess some understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation.

Develop capability to provide technical support during audits and inspections.

Develop capability to train necessary staff on equipment operation.

Understand importance of safety in the workplace and contribute to safety awareness in the department.

Understand importance of quality in the workplace and contribute to quality awareness in the department.

Projects/Activities:

Efficiently and effectively manage assigned projects and initiatives.

As 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.

Develop understanding of project management methodologies and tools to advance assigned projects.

Develop organizational awareness.

Problem Solving

Provide solutions to a variety of technical problems of moderate scope and complexity, which are verified by supervisor for technical accuracy and merit.

Develop understanding and use of 5 Whys, Level-0, and Practical Problem Solving.

Demonstrate rudimentary problem-solving skills related to finite troubleshooting and project execution challenges.

Emerging understanding of how the stakeholder organization(s) functions and who should contribute to a problem-solving process.

Emerging understanding of how to balance and integrate core function and project objectives.

Coordinate risk mitigation and contingency scenarios for projects and ensure practical implementation of agreed recommendations.

Demonstrate a composed manner when dealing with issues, challenges, conflicts, and opportunities.

Be creative and flexible in identifying and implementing solutions.

With guidance and coaching, able to contribute and apply learnings and best practice from projects/activities and share with group and colleagues.

Support 24X7 operations as on-call support