Lead Process Engineer

AstraZeneca • Frederick, MD

2d • $108,194 - $162,291 • Onsite

About The Position

Process Engineering is responsible for providing technical support to the manufacturing and logistics buildings at the Frederick Manufacturing Center (FMC) for troubleshooting, modifications and improvements related to process, clean-in-place, steam-in-place, washing, and sterilizing equipment systems. This role is a unique opportunity to contribute to our ambitious sustainability strategy and make a real difference in our Operations department.

Requirements

• Bachelor of Arts or Science in Engineering or Life Sciences
• 5 years or more of applicable experience
• 3 years or more of pharmaceutical, biotech or life sciences experience
• Possess some technical skills and knowledge with biopharmaceutical operations, process/utility equipment, and automated systems.
• Possess some understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation.
• Fundamental understanding of biopharmaceutical processes and equipment through coursework or previous work experience.
• 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.
• Proficient in computer skills and MS Office applications.
• 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: Upstream equipment: Incubators Bioreactors Centrifuges Pasteurizer Downstream equipment: Chromatography columns Viral inactivation Ultrafiltration Diafiltration Freeze/thaw
• 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.
• Ability to use process data (i.e., temperatures, pressures, valve sequencing, etc.) to solve equipment-related issues.
• Familiar with the regulatory audit process and capable of gathering supporting documents.

Nice To Haves

• Develop an understanding of equipment, processes, and automated system design through coaching and support.
• Understanding of Lean concepts and waste reduction.
• Develop understanding of project management methodologies and tools to advance assigned projects.
• Develop organizational awareness.
• Self-starter.
• Primarily internal company contacts, with some interaction with vendors and contractors.
• Frequent interaction within teams across departments.
• Possess ability to convey ideas and concepts to others.
• Apply stakeholder management principles within a matrix environment building productive relationships with key interfaces and stakeholders.

Responsibilities

• Scope, 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.
• 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.
• 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.
• 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.
• 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.
• Lead moderate cross-functional teams to complete work.
• Identify issues and seek input from manager for appropriate resolution.
• Expected to prioritize and organize activities effectively to align with the needs of the group and established goals and objectives.
• Empowered to work within the organization to ensure the progression of assignments.
• Contribute to the completion of milestones associated with specific activities.
• Progress assigned activities through key milestones on time and to budget to meet required deliverables.
• Develop goals that align and support department goals and priorities.
• Understand how to work within their department and be a good ambassador for your group.
• Seek opportunities to develop expertise within your group and enhance your professional reputation though learning, continuous improvement, and applying best-practices.
• Use appropriate communication techniques/tools to work effectively and collaboratively in a complex manufacturing environment.
• Ability to negotiate with customers and stakeholders using decision making tools (DAI).

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior