Project Development Specialist
The Project Development Specialist will be responsible for assisting with the development of engineering projects through design, implementation, and operational readiness in collaboration with multiple stakeholder groups.
* Support the expansion of existing facilities by focusing on filling, inspection, and formulation equipment.
* Develop a manufacturing readiness strategy to ensure new systems and equipment meet client standards and are fit for purpose.
* Collaborate with diverse groups including Manufacturing, Quality, PD, Automation, IS, EHSS, and Global Engineering to ensure project delivery.
* Evaluate maintenance strategies and develop initial PM programs for process equipment.
* Travel as required to support project execution.
Essential Qualifications/Experience:
* A Bachelor's Degree in Engineering (Mechanical, Electrical, or Chemical) with typically 4+ years of experience in engineering projects and systems.
* Fundamental knowledge of applicable quality management and regulatory requirements.
* 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.
* A team player who actively promotes a culture of clear communication, collaboration, and engagement at all relevant levels for effective decision-making.
* Manufacturing experience in a biopharmaceutical formulation/fill/finish facility.
* Strong technical ability to understand and resolve complex problems as part of a focused and high-performing team.
* Experience in vendor management and contract negotiations with a focus on equipment suppliers.
* Independent, self-motivated, organized, and able to multi-task in project environments.