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Company

BioSpace · 6 hours ago

Senior Project Process Engineer

Massachusetts, United States

Full-time

Remote

Senior Level

5+ years exp

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Comp. & Benefits

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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 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&IDs (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.

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.

Qualification

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Engineering DegreeBiopharmaceutical ManufacturingCGMP ExperienceProject Management SkillsPMP CertificationInstrumentation ServiceCalibrationMetrologyP&ID DrawingsDocumentation PracticesLeadership AbilitiesCollaboration Skills

Required

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.

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 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.

Preferred

Possession of PMP certification is a plus.

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.