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Job Description:

Support the deployment of the MTO aspiration “to innovate to safely supply quality products and services competitively, faster, always”. Responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facilities, systems, and equipment; and providing engineering and technical/business support for new complex production technologies and processing equipment, production network analysis, and Synthes of technology and case analysis. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to support ‘right first time’ execution and start up.

Develop integrated business solutions for new technology strategies and introduction into manufacturing, site analysis, and strategic manufacturing projects. Develop and deploy process fit to plant methodology that ensures all aspects of the manufacturing process technical transfer are comprehensively and consistently ‘done right’. Leverages internal and external expertise and applies principles of Knowledge Management to drive innovative solutions in engineering support, and process technology. Coordinate with Technical Operations platform to ensure project alignment with technology standards and engineering specifications for manufacturing technology. This is intended to be a general job description and should not be construed as all-inclusive.

Key Responsibilities:

• Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize and execute project plans as SME and process systems owner. The incumbent should demonstrate the following: detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements.

• Serve as Process Engineering Expert to develop business based technology solutions and provide integrated equipment, utility, and facility engineering expertise with an operational focus to support execution of strategic and key CAPEX manufacturing projects, driving ‘right first time’ start up and execution.

• Provide strong technical leadership and expertise for technology transfers and new technology development projects to ensure process fit to plant methodology and practices..

• Explore and understand Technology and Manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions.

• Provide technical leadership of multi-functional teams on many projects/ process improvements and resolves inter-functional issues.

• High degree of collaboration with internal (manufacturing, quality, engineering) to develop standards and define project needs and priorities; as well as recruiting project team members.

• The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, and interdependent partnering, conflict and risk management.

Qualifications

Education:

• Minimum of a Bachelor's or equivalent University Degree in engineering (preferably Chemical or Mechanical) required;

• MS/MBA/Ph.D. PE Certificate preferred

Experience and Skills:

Required:

• A minimum of 8 years of process/plant engineering experience in GMP MFG large molecule biologics facilities.

• Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities and operations.

• Strong technical background in Process and Manufacturing engineering, strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions Operational and financial fundamentals

• The ability to lead and/or support multiple projects simultaneously

• Defines technical or scientific direction of programs composed of multiple complex projects

• Engineers new and modifies existing processes to ensure right first time process start up

• Track record of successful program execution and team outcomes

Preferred:

• FPX certification and Six Sigma and/or Lean experience

Other:

• This position is located in Wilson, North Carolina, and will require full time on-site support.

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