Sr Engineer – Process & Equipment

Career Category

Engineering

Job Description

Process & Equipment Engineer

Overview:

Reporting to the Principal Engineer, this person, is part of the team supporting commercial manufacturing with a focus on Vial filling equipment. The position will support complex and challenging manufacturing initiatives.

As a member of the Process & Equipment Engineering team, the role will support complex and challenging manufacturing initiatives.

Key Responsibilities:

• Ownership of equipment/systems in a GMP regulated manufacturing setting
• Support Drug Product manufacturing processes
• Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures
• Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems
• Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs
• Solving complex problems, project management, equipment lifecycle management and operational excellence
• Develop and manage change control requests per established SOPs and processes
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

Preferred Qualifications

• Bachelors in Engineering (Mechanical, Electrical or Chemical)
• Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
• Solid leadership, technical writing, and communication/presentation skills
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices
• Experience in developing strategies for new product introduction and new technology deployment
• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
• Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate
• Ensure application of corporate blueprint and standards using business drivers to local business needs
• Development and presentation of project plans to senior management
• Day to day vendor management and contract negotiations with focus on equipment suppliers
• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

Travel at various times may be required to support execution of projects

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