Overview:
The role is responsible for assisting with the Engineering elements of the expansion project through design, implementation, and operational readiness in collaboration with multiple stakeholder groups.
Key Responsibilities:
* As a member of the Engineering team, support the expansion of the existing manufacturing facility, focusing on filling, inspection, and formulation equipment.
* Support the manufacturing readiness strategy, startup, and validation of new systems and equipment to ensure requirements are in line with the clients standards and fit for purpose.
* Assist with equipment project deliverables of setup, calibration, spare parts management, functional testing, and start-up support.
* Ensure consistency in equipment design and practices, with a focus on simplifying processes and tasks.
* Collaborate with diverse groups including Manufacturing, Quality, PD, Automation, IS, EHSS, and Global Engineering to ensure project delivery.
* Establish maintenance strategies and develop initial PM programs for process equipment.
* Travel as required to support project execution.
Basic Qualifications/Experience:
* Minimum of 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.
* 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.
