Overview
Project Engineer (Senior)
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.
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 withstandards 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.
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