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