Capital Project Engineer

Role Summary

Capital Project Engineer at AbbVie Bioresearch Center to manage and execute capital projects involving design, installation, and renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP environment.

Responsibilities

• Providing overall management of capital projects through the entire project life-cycle including scope management, scheduling, budgeting and coordinating activities interdepartmentally and with contractors.
• Project scope development based on customer requirements, cost estimation, request of capital expenditure and preparation of financial defense package, scheduling, resource allocation, vendor and contractor management, and status reporting.
• Conducting design reviews including specifications, procurement, fabrication management, and installation of equipment, facilities, and utilities related to the manufacture of biologics bulk drug substance including basic unit operations involving fermentation, cell culture and protein purification and related equipment.
• Development of user requirements, biologics equipment P&ID‚Äôs (Piping and Instrumentation Diagrams), technical/functional specifications to support automation programming and processes.
• Performing engineering calculations required to size process lines, equipment, and instrumentation, procurement and fabrication management involves reviewing and approving piping, instruments, and equipment proposed by a vendor or field contractor based on the suitability of the proposed item to perform as designed, and completing installation design by providing the required utilities, space, piping, and environmental controls required to operate the area or equipment as designed;
• Identify project resources needs both internally and externally.
• Assist in the procurement process and generate purchase requisitions for all project equipment and labor purchases according to relevant Abbvie policies and procedures.
• Reviews mechanical design of all vendor-fabricated equipment, including review and approval of all vendor submittals with internal stakeholders, and preparation/execution of factory and site acceptance testing (FAT / SAT) protocols
• Participates in biopharmaceutical and pharmaceutical validation activities of equipment, facilities and utilities to ensure the system is installed as designed, operates within the design parameters, and is capable of performing as designed to produce the intended product or environment.
• Prepare and deliver periodic project status reports to all internal project stakeholders (internal customers, engineering and plant management, etc) according to Abbvie site policies.

Qualifications

• A Bachelors Degree in Engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 2 to 6 years of significant engineering and/or operational experience. Additional post-graduate education may contribute towards the desired years of experience.
• Has demonstrated competency within a discipline.
• Possesses a working technical knowledge and application of concepts, practices, and procedures. Ability to work on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Demonstrates judgment within defined procedures and practices to determine appropriate action.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
• Works well with other engineers in a collaborative, fast-paced goal-driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences.
• Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).