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 and technology introductions by performing engineering assessments, implementing system changes, and supporting engineering runs
* Address complex problems, manage projects, oversee equipment lifecycle, and promote operational excellence
* Develop and manage change control requests according to SOPs and processes
* Support a safe working environment by complying with all environmental health and safety regulations
Preferred Qualifications:
* 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 skills
* Experience with change control, non-conformance, CAPA, and validation practices
* Experience in developing strategies for new product and technology deployment
* Ability to translate strategic opportunities into practical, executable plans
* Ability to influence business and engineering strategies
* Application of corporate standards aligned with business needs
* Experience in developing and presenting project plans to senior management
* Vendor management and contract negotiation skills, especially with equipment suppliers
* Self-motivated, organized, capable of multitasking in project environments, with strong communication skills
* Team-oriented, collaborative, and adaptable to team-based decision-making environments
Travel may be required at various times to support project execution.
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