IM CSV Lead

Profile

Who We Are BioMarinu2019s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarinu2019s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Role SummaryThe Enterprise Services team seeks a highly talented and motivated CSV Lead to implement and improve IT systems within the TOPS organization. This position reports to the CSV Services Lead in the Technology Foundation department of IM and will be responsible for the implementation and maintenance of GxP validated computerized systems, throughout their lifecycle, with a particular focus on the Shanbally site. The CSV Lead will ensure that validation activities are performed within the framework of the Computer Validation Policy and be capable of educating stakeholders on the validation process. Other responsibilities will include contributing to the continual improvement of validation practices and acting as a process owner for elements of the validation policy, as assigned.The CSV Lead will participate in the development of custom programs, as well as configurable off the shelf (COTS) systems. Duties include ongoing evaluation and periodic review of existing validated computer systems; change control; and oversight of a team of consultants assigned to validate new computer systems. This position will be responsible for the oversight of all CSV initiatives particularly at the Shanbally facility including resource management, spend tracking, and workload forecasting. Other responsibilities of this position include review and approval of validation deliverables and SDLC documents, contractor management and other duties as assigned. The person will partner with Global IT technical teams to translate business/system requirements into well designed technical solutions, ensuring the end-state solution matches the business requirements. This person is also responsible for the business process analysis, solution deployment, administration, maintenance, and support of our Application Lifecycle Management System.The position may require minimal travel.Duties include: Responsibilities Implementation and Maintenance of validated Computerized / Enterprise systemsu00A7u00A0 Adhering to the u2018Computer Validation Policyu2019u00A7u00A0 Educating stakeholders on the Validation Processu00A7u00A0 Acting as the Process owner for IT-CSVu00A7u00A0 Ensuring Data Integrity and Quality Compliance u00A7u00A0 Identifying the Validation approach and scope for computer/enterprise systemsu00A7u00A0 Evaluation and Periodic review of existing validated systemsu00A7u00A0 Review and approval of validation deliverables and SDLC Documentationu00A0 u00A7u00A0 Project Management, Resource Loading and Forecastingu00A7u00A0 Acting as a Mentor for Menteesu00A7u00A0 Change Control Review & Approvalu00A7u00A0 Collaboration/Implementing Process Improvementsu00A7u00A0 Attend Project Meeting and Computer Validation Forumu00A7u00A0 Co-ordination between internal departments u00A7u00A0 Represent IM-CSV at Shanbally u00A7u00A0 Attend Conferences and Training Seminars to align with industry practicesResource Managementu00A0u00A7u00A0 Agency Setup / Point of Contactu00A7u00A0 CV Vettingu00A7u00A0 Performing Interviews u00A7u00A0 On boardingu00A0 / Off boarding Consultants u00A7u00A0 Timesheet review & approvalu00A7u00A0 Costing and PO Generationu00A7u00A0 Invoice review & approvalu00A7u00A0 Trainingu00A0Trainingu00B7u00A0u00A0u00A0u00A0u00A0u00A0 Gather training requirements u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Train new users on IT-CSV Procedures and Policiesu00B7u00A0u00A0u00A0u00A0u00A0u00A0 Providing Training materials to the end usersu00B7u00A0u00A0u00A0u00A0u00A0u00A0 Role out and participation in the Computer Software Assurance (CSA) Initiative.System Supportu00A0u00A7u00A0 ALM Admin/SMEu00A7u00A0 UAT Testing & Developmentu00A7u00A0 TrainingContact/SME for Regularity Inspectionsu00A7u00A0 Documentation Prep.u00A7u00A0 System Review and Tidy upu00A7u00A0 Trainingu00A7u00A0 Point of contact for IT-CSV deliverablesu00A7u00A0 Participation and active member of the site inspection teamu00A7u00A0 Present information to regularity, partner and internal auditors as required.u00A7u00A0 Represent IM at Shanbally meeting involving CSV topics.u00A0Education Required Minimum of an Computer Science or Engineering/Science Degree with minimum 6 yearsu2019 experience in a Bio-Pharmaceutical or equivalent type industry. Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point, MS AccessExperience Requiredu00A0 Good verbal and written communication skills. Good organizational skills. Experience in coordination staff, and/or experience in project management. Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination. Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements. Must possess a thorough understanding of current industry guidance, including GAMP 5 Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them. Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Power Point). Proficiency with ITIL concepts and ServiceNow Experience with ALM, Veeva, Service Nowu00A0Supervisory Responsibilityu00A0This person will have consultants/contractors reporting to the.u00A0Competencies RequiredRole Level Criteria Strategic Contribution & Impact Establishes operational objectives and work plans. Delegates assignments to subordinates. Reviews objectives to determine success of operation. Financial Impact & Value Creation Impact on department . Scope and Complexity Works on issues of diverse scope where analysis of situation requires evaluation of a variety of factors, including an understanding of industry trends. Follows processes and operational policies. Creates formal networks involving coordination among groups. Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation to others. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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