Senior Project Process Engineer

6 hours ago

Worcester, Massachusetts, United States AbbVie Full time
Job Summary

A challenging opportunity has arisen for a Senior Project Process Engineer to join our team at AbbVie Bioresearch Center in Worcester, MA. As a key member of our Project Engineering group, you will play a crucial role in the management and execution of capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment.

Key Responsibilities
  • Provide overall management of capital projects through the entire project life-cycle, including scope management, scheduling, budgeting, and coordinating activities interdepartmentally and with contractors.
  • Develop project scope 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.
  • Conduct design review, 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.
  • Develop user requirements, biologics equipment P&ID's (Piping and Instrumentation Diagrams), technical/functional specifications to support automation programming and processes.
  • Perform 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.
  • Oversee 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.
  • Manage 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.
Requirements
  • Bachelor's Degree in Engineering, Science, or a closely related discipline.
  • Equivalent technical experience with a minimum of 5 years of significant engineering and/or operational experience.
  • Strong experience in biopharmaceutical manufacturing and/or biologics equipment operation/troubleshooting.
  • Possession of PMP certification is a plus.
  • Excellent verbal and written communication skills.
  • Experience with cGMP and Good Documentation practices.
  • Technical expertise in Engineering, Maintenance, Instrumentation Service, Calibration, and Metrology is highly beneficial.
  • Ability to work well in a team, collaborate effectively, and demonstrate strong interpersonal skills.
  • Effective project management skills, including the ability to manage multiple projects simultaneously, and excellent planning and organizational skills.
  • Familiarity with P&ID drawings, loop diagrams, one-line schematics, etc.
  • Strong leadership abilities, teamwork skills, and the capability to maintain positive relationships with personnel from different disciplines and levels within the organization are highly desired.
  • Strong technical knowledge and application of concepts, practices, and procedures.
  • Ability to handle complex problems involving multiple competing factors and exercise judgment within defined procedures and practices.
  • Ability to interact effectively with diverse groups within engineering and maintain strong working relationships with both internal and external collaborators.
  • Ability to convey ideas and information effectively through verbal, written, and presentation channels.
  • Strong collaboration skills and the ability to work well with other engineers in a fast-paced, goal-driven environment.

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