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Job: Engineering Manager, Medicago USA, Durham, NC
Durham, NC 27713 United States
The Engineering Manager provides management and leadership for the Site Engineering function that support the Medicago Durham RTP site by directing the relationships and processes for execution of the Engineering Services department vision. This position ensures that the Site Engineering team provides the proper operational support through technical SME’s and execution of capital projects to meet the business needs of the site.
• In cooperation with the Site Maintenance Services Leadership Team, develop the strategic capital program for the department and execute, by providing leadership and direction of its personnel, contractors and consultants, understanding department responsibilities and priorities, and then adjusting the programs accordingly.
• Ensure efficient and effective operation by creating a proactive environment, developing & monitoring metrics, and communicating with End Users to add increased value to the business.
• Participate as a key member of the Management Team by cooperating cross functionally to achieve Operational Priorities and Site Performance.
o Ensure that the Engineering team understands the shared accountability for Goals and Priorities within Operations.
• Provide people and team development for increased company value and personal satisfaction. Work with department teams to ensure success and encourage collaboration and networking across all functions.
• Ensure compliance with all regulatory requirements and good documentation practices are followed to track all projects and make data analysis efficient.
• Participate in the development of a strong Safety Culture that encourages building into all projects safety awareness, programs and solutions as part of the project elements.
• Responsible for the management of the engineering department and site engineering projects from pre-concept to post turnover
• Provide Project Management for facility projects, new equipment installation, and new construction
• Develop and maintain site Engineering standards and specifications
• Develop a Capital Investment plan to support the transition and maintenance of the commercial manufacturing capability
• Develop site engineering staff and competencies and organizational capability
• Ensure department capital projects meet safety, scope, quality, schedule and budget as required to support site operations and company needs.
• Develop, manage and track CAPEX budgets
• Develop and implement a structured Project “Stage Gate Process” to ensure the quality of work, using formal user requirements, functional specs and process documentation including Commissioning and Qualification programs
• Improve process optimization and operations through active engagement with end users after commissioning/IQ/OQ/PQ.
• Integrate organization into efficient processes with Maintenance, Validation, Quality and Operations
• Support the development and maintenance of a Site Master File
• Maintain and update the documentation of facilities and equipment parameters including mass balance and P&ID’s as required, preferably with an electronic tool
• Responsible for department Change Controls, CAPAs, Engineering Change Management program during project execution and Site Drawings.
• Ensures proper management of project closeouts including Turnover Package development and/or revisions
• Works with technology transfer groups to assure success in process start-up.
• Sitting for extended periods of time.
• Dexterity of hands and fingers to operate a computer keyboard, mouse, and other devices and objects.
• Lifting and transporting of approximately 50 lbs.
• Strong understanding of project management principles related to scope, budget and schedule control and a working knowledge of Microsoft Project,
o Manages and coordinates the activities of a project with responsibility for results in terms of costs, methods and employees
• Clear understanding of the regulations governing the manufacture of pharmaceutical and biological products
• Demonstrated ability to lead cross-functional project teams.
o Capable of building and developing a core team to support site operations
• Working knowledge of AutoCAD
• Working experience around the development and execution of qualification protocols for pharma/biotech manufacturing facilities
• Provides technical solutions to a wide range of engineering challenges. Solutions are imaginative and pragmatic, thorough, practicable and consistent with organizational objectives and local code requirements
• Understanding of process design and transfer for biopharmaceutical processes
• Possesses excellent problem-solving skills and ability to analyze complex interactions
• Able to communicate effectively with diverse groups to resolve critical issues across multiple functional areas
• Adherence to all health, safety & environmental requirements in support of departmental and site goals. Work in a safe and efficient manner.
• Requires a Bachelors or Masters in an engineering discipline with 10 years or more experience in facilities engineering and/or 7 years in the pharmaceutical or biotech production facilities.
• Experience in commissioning and qualifying facilities producing material according to cGMP requirements
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