Jobs for People with MS: National MS Society

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 within the Vial Filling area

• 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:

• Bachelor’s degree 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