Job Description:

• The primary location for this role is Wilson, NC. Design is taking place in Conshohocken, PA. The design phase requires a hybrid work location of remote and onsite in Wilson, as well as routine travel to Conshohocken. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site full-time in Wilson, NC.
• This role reports to a System Owner – Area Lead within the System Owner team. The System Owners will be assigned several pieces of equipment and areas within the production building scope.
• The main role for the System Owner (Engineering SME) is to act as project manager and technical subject matter expert for their systems for the duration of the project from design to construction, until commissioning and qualification is completed.
• This is intended to be a general job description and should not be construed as all-inclusive.

Responsibilities:

• Extensive interaction with A&E firm, equipment vendors, automation vendors and construction manager to develop, organize and execute project plans.
• Accountable for scope, cost and on-time delivery of process equipment from design to start-up.
• Collaborating closely with system user, project engineering, construction management, PMO, C&Q and automation to ensure the user requirements are met through all phases of the project.
• Addresses any conflicts in design, construction or at the field and elevate any issues that require management input.
• Responsible for verifying that the requirements of the URS are incorporated into the design.
• Participate in 3D model reviews to confirm operability and maintainability of equipment.
• Manages FAT & SAT including review and approval of protocols, planning vendor visits, and overseeing execution and resolution of punch-list items.
• Ensure that all EHS-by-design (EBD) requirements are incorporated in the equipment bidding (front-end definition), purchase packages and design documents.
• Attend the system walk downs during construction and organize the owner side of the walk down.
• Approve of the System Commissioning Test Plans (CTP) pre and post execution.
• Review (technical accuracy and acceptability of complete system) Engineering Turnover Package to ensure they are in accordance with Engineer / Manufacturer / User Specifications and Drawings
• Assist in the turnover of the documentation for their system to the owner document control system.
• The incumbent should demonstrate the following: sense of urgency, detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements.

Requirements:

• Minimum of a bachelor’s or equivalent University Degree required in chemical or mechanical engineering
• A minimum of five (5) years of process/plant engineering experience in GMP MFG large molecule biologics facilities.
• Experience overseeing process equipment vendors and A&E firms project delivery is required.
• Experience and technical expertise with large scale monoclonal antibody manufacturing equipment is required. Technical expertise in centrifuges, depth filtration, single-use solution prep and storage, and closed filling systems is preferred.
• Experience in green or brown field GMP manufacturing facility start-up including process systems, automation, utilities, facilities, C&Q, and operations is preferred.
• Strong technical background in Process and Manufacturing engineering.
• The ability to lead and/or support multiple projects simultaneously.
• Engineers new and modifies existing processes to ensure right first-time process start up.
• Experience with review and approval of deferent engineering documents and drawings
• Ability to travel and lead Factory Acceptance Tests of process equipment
• This position may require domestic or international travel based on project business needs.
• Routine travel to Conshohocken, PA required through the end of the detailed design phase.
• Travel to equipment vendor locations required through the end of equipment delivery.
• Full-time onsite work in Wilson, NC required during construction and start-up phase.

• Extensive interaction with A&E firm, equipment vendors, automation vendors and construction manager to develop, organize and execute project plans.
• Accountable for scope, cost and on-time delivery of process equipment from design to start-up.
• Collaborating closely with system user, project engineering, construction management, PMO, C&Q and automation to ensure the user requirements are met through all phases of the project.
• Addresses any conflicts in design, construction or at the field and elevate any issues that require management input.
• Responsible for verifying that the requirements of the URS are incorporated into the design.
• Participate in 3D model reviews to confirm operability and maintainability of equipment.
• Manages FAT & SAT including review and approval of protocols, planning vendor visits, and overseeing execution and resolution of punch-list items.
• Ensure that all EHS-by-design (EBD) requirements are incorporated in the equipment bidding (front-end definition), purchase packages and design documents.
• Attend the system walk downs during construction and organize the owner side of the walk down.
• Approve of the System Commissioning Test Plans (CTP) pre and post execution.
• Review (technical accuracy and acceptability of complete system) Engineering Turnover Package to ensure they are in accordance with Engineer / Manufacturer / User Specifications and Drawings
• Assist in the turnover of the documentation for their system to the owner document control system.
• The incumbent should demonstrate the following: sense of urgency, detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements