Project Engineer

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Project Engineering group. The selected candidate will be responsible for 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.

Responsible for the management of capital projects involving biologics related equipment, facilities, and utilities, including the following:

• 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 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.
• Development of user requirements, biologics equipment P&ID's (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.
• 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
• Managing 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

Qualifications:

Education

• BS in Chemical or Mechanical Engineering with a minimum of 6 years of relevant "hands on" work experience is required.

Background

• A background in biopharmaceutical manufacturing and/or biologics equipment operation/troubleshooting is strongly preferred.
• PMP certification a significant advantage
• Good oral/written communication skills
• cGMP and Good Documentation experience required.
• Technical Experience (Engineering, Maintenance, Instrumentation Service, Calibration, and Metrology, etc.) a significant advantage
• Demonstrated interpersonal, collaboration and effective teamwork skills required a considered a significant advantage.
• Ability to manage multiple projects effectively, possesses excellent planning and organizational skills
• Familiar with P&ID drawings, loop diagrams, one line schematics, etc.
• Knowledge of Microsoft and other software packages.
• Teamwork, leadership and the ability to maintain constructive relationships with personnel from various disciplines at all levels in the organization are desired competencies.
• The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation and self-motivation.

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.