Equipment Engineer Role Summary
This role will support manufacturing initiatives within the vial filling area, ensuring the efficiency and quality of equipment. Reporting to a Principal Engineer, this position is part of a team that oversees commercial manufacturing with a focus on equipment systems.
Main Responsibilities:
• Equipment ownership in a GMP regulated setting
• Support drug product manufacturing within the vial filling area
• Lead system improvements, detailed specifications, engineering documents and standard operating procedures
• Conduct technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems
• Implement new technologies by performing engineering assessments, implementing system changes and supporting engineering runs
• Solve complex problems, manage projects, equipment lifecycle management and operational excellence
• Manage change control requests per established SOPs and processes
• Maintain a safe working environment by complying with all pertinent health/safety practices, rules and regulations
Requirements:
• Bachelor's degree in Engineering (Mechanical, Electrical or Chemical)
• Manufacturing experience in biopharmaceutical formulation/fill/finish or API facilities
• Strong leadership, technical writing and communication/presentation skills
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices
• Ability to translate strategic opportunities into executable plans
• Team player, prepared to work in a collaborative culture for effective decision-making
Preferred Qualifications:
• Solid experience in project management, contract negotiations with vendors, and vendor management
• Ability to develop and present project plans to senior management
Travel may be required at various times to support project execution