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Senior Engineer, IT GMP Site Systems

Winston-Salem, North Carolina, United States

Senior Engineer, IT GMP Site Systems

Responsibilities

  • Implementation and support of technology and informatics systems/tools and programs to support the development, implementation, operation, and continuous improvement of GMP Technical Operations including but not limited to manufacturing, quality assurance, quality control, supply chain, patient experience, facilities/engineering, and technical development.  
  • Serve as an overall business partner for day-to-day activities and support WestPoint Site Operations. The senior engineer will support all facets of site support including identification of business needs, crafting solutions, implementation of site digital capabilities, addressing issues, and provide status to site teams. The associate director, GMP Site Systems, will report to the Senior Director, GMP Systems.  The senior engineer will partner with other internal IT teams such as IT assurance and compliance, program management, and IT operations to meet business needs.
  • The scope of work will include day-to-day support and maintenance of all site GMP systems as well as supporting strategic projects.   The support will require supervising internal and external staff involved in support of GMP systems.  The support responsibilities span implementing and optimizing support for GMP systems. This would include implementing necessary site metrics and the Service Level Agreement (SLA) for the support for critical systems and then ensuring that all incidents and improvements are carried out to meet business needs in alignment with agreed SLAs.  The Senior Engineer will ensure that all IT systems in GMP operations either managed directly and indirectly continue to meet the needs of site manufacturing and minimize any disruptions to business continuity objectives.
  • The scope of systems may include ERP, MES, Electronic Batch Record, Laboratory Systems, Quality Management, Document Management, Facilities management, GMP Labeling, Barcoding, Shop-Floor Systems, and data management and analytics.  The senior engineer will work with other members of GMP IT team and stakeholders to help drive digital transformation to support goals for clinical and commercial manufacturing. The position will provide oversight of contractors and external partners to provide the oversight.

Qualifications

  • 5-10 years of implementing and supporting IT within manufacturing/supply chain in biotechnology or life sciences companies.
  • The position requires a broad understanding of GMP regulatory frameworks and obligations. This is a highly integrated role touching many functions across the business and requires the ability to translate business problems into technology solutions, project plan, and project manage, to drive alignment and performance across the business.  The position requires enthusiasm, passion, attention to detail and a desire to create new medicines for patients.
  • Experience with oversight of day-to-day critical GMP IT systems is a Must.
  • Strong Working Experience in developing and driving Computer System Validation program initiatives including GxP systems and ensuring CFR part 11 compliance.
  • Experience leveraging digital systems to drive business workflows and processes in quality-manufacturing production environments.
  • Experience with shop floor automation, ERP, MES, Quality, Laboratory, Warehouse, Engineering/Facilities, Supply Chain, and Chain of Custody/Chain of Identity,
  • Experience with implementing and automation of warehouse.
  • Experience with Manufacturing Execution System/ Electronic Batch Record
  • Experience with commissioning and validation of shop-floor equipment and devices
  • Previous experience working in GMP Environment is required.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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