Systems Administrator, Cell Manipulation Core Facility

• The System Administrator III will work internal to the Cell Manipulation Core Facility to manage systems across the Cell Therapy (CT) Networks by implementation and validation of computer systems impacting the department and CT program. The System Administrator III works in conjunction with the project teams from Partners Healthcare System and CMCF technical staff as well as working with DFCI and Partners IS on enterprise systems such as Epic and Sunquest. Systems will include, but are not limited to Partners Order Entry System for Biological Products (BOE/BPAA), Eceptionist, Sunquest, REES Environmental Monitoring systems, Internal Server systems, CMCF FileMaker Databases, FreezerWorks Bio-Repository system selected MES, and other internal systems such as Microsoft Access and Filemaker databases
• Demonstrates knowledge of CMCF, clinical and laboratory workflow to incorporate and propose design consideration for CMCF applications
• Examines existing business models and flows of data in CT and assists to implement and support the IT manufacturing solutions for the CMCF
• Performs thorough data and system analyses and develops a risk-based analysis understanding
• communicates the consequences that erroneous data could have on patient care
• Creates and maintains the procedures for system use, maintenance, and validation documents for upgrades and continuity of care during down time
• Identifies critical data and coordinating / consolidation of existing data systems into the appropriate secure database
• Manages all internal computer systems used by the facility and assists in the compilation of relevant data as required for ongoing analysis and quality improvement
• Manages the team that submits data to the CIBMTR either via OTTR registry agent or formsnet3
• Assists in the implementation / management of software needs for various transfusion management activities for DF clinical lab and teams
• Creates reports for transfusion related data needs for transfusion management and compliance reporting
• Compiles data from the appropriate database for analysis of quality assurance indicators, as required for FACT, accreditation bodies, sponsors and for individual protocols, etc.
• Works with department programmer to ensure new programs are validated in compliance with regulatory requirements and that applications are rolled out in an acceptable timeframe
• Manages the design, development, testing, implementation and on-going maintenance of new and existing internal applications within the CMCF and integration into CT clinical systems
• Provides user support and develops a business continuity back-up plan for system downtimes, and reports/responds to user issues
• Manages and supports department servers as well as facilitates acquisition of new and replacement servers as needed
• Provides support in the maintenance and security of the manufacturing system and their interfaces
• Works with Partners project teams to help develop work plans and timelines for new applications/system implementations as well as upgrades
• Facilitates group projects towards successful completion of goals
• Manages internal projects within the context of the larger environment including competing priorities, staffing levels, and budgetary concerns
• Communicates work and project status to management and team members
• Aids in development of training plans and materials for various applications as well as conducts end-user training
• Performs super-user and end-user training of applications, responsible for new system implementations and existing system upgrades
• Independently creates test scenarios and executes validation testing to meet regulatory requirements
• creates, documents and executes functional and system test strategies
• Works with vendor-supplied systems to perform quality checks on the interfaces that link vendor applications to in-house applications
• Identifies complex problems, their probable causes, their impact on operations, reports them appropriately, and offers possible solutions, and decides on optimal course of action
• independently, or collaboratively, bring problems to complete resolution
• Works with teams, both internal and external to DFCI / Partners, to ensure systems remain compliant with both regulatory and accreditation requirements for electronic record keeping systems and instrument/ network exchange
• Ensures that regulations and standards are incorporated into the design of the manufacturing systems and ensures adherence to standards/regulations during implementation and ongoing
• Performs periodic audits as part of ongoing quality assurance of all data systems
• Plans and executes audits of current IT policies and procedures
• Institutes corrective actions for any policies and procedures that are out of compliance
• Evaluates workflows and improves processes using automation and information systems
• Provides ongoing review of all internal CMCF computer applications to ensure lab systems and procedures are HIPAA compliant and work with DF Information Security Officer to ensure compliance
• Manages the authorization and security functions of select systems
• Serves as a contributing member on various institution IS committees (Epic, Sunquest, BOE DFCI/MGH Steering Committee)
• Communicates with or works with appropriate department when troubleshooting department applications
• Interfaces with DFCI information security officer and team to ensure compliance in sharing information (including PHI) with outside sponsors

• Knowledge of lab safety and infection control
• Knowledge of cell therapy processing, medical, hematologic, oncologic and scientific terminology
• Knowledge of Web publishing, ODBC/JDBC interfaces and SQL
• Knowledgeable of BOE template builder and ability to collaborate/train on the builder
• Ability to assess workload and prioritize and delegate tasks
• Ability to accommodate schedule adjustments, as well as off-shift and weekend assignments as workload dictates
• Excellent customer service skills and demonstrated ability to develop effective internal working relationships with a diverse employee population
• Strong project management skills
• Demonstrated competence in managing system projects
• Demonstrated competence in writing and executing validation plans
• Strong written and verbal communication skills
• Strong analytical and problem-solving skills
• Ability to understand the enterprise environment and competing priorities in conjunction with developing/ meeting project goals
• Requires an ongoing commitment to upgrading of technical skills
• Capable of working in a fast-paced environment, effective in a diverse work group, willing to work in a rapidly changing field
• Ability to create and validate applications for databases and pivot tables for spreadsheets
• Ability to assist vendors working with Partners IT in managing Network servers
• Ability to perform system scripting, programming and generate reports critical to department operations and compliance
• Ensures compliance of systems with 21 CFR part 11, cGDP, accrediting bodies (FACT, JC), Security Industry Practice both current and applicable practices as defined in the International Organization for Standardization (ISO/IEC) ISO/IEC ISO27001, ISO/IEC 27002:2013, SSAE-18, ISAE3402, National Institute of Standards and Technology (NIST) NIST 800-53, the Open Web Application Security Project (OWASP) Guide to Building Secure Web Applications, and the Center for Internet Security (CIS) Standards (or any successor to these security standards) or any other industry security standards mutually agreed by Parties
• Training and working knowledge of Sequel and/or other relevant programming language
• Must have working knowledge of flow of data and data structure through complex IT architecture systems
• Ability to effectively interact independently
• facilitate decision making with users and administrative leadership in multiple venues and environments
• Ability to follow industry qualifications standards for the design (DQ), implementation (IQ), operational (OQ) and performance (OQ) testing and documentation
• Stay current with industry trends as related to job responsibilities
• able to incorporate impact of industry trends into how systems are designed, tested, implemented, and supported
• Working knowledge of Security Industry Practice both current and applicable practices as defined in the International Organization for Standardization (ISO/IEC) ISO/IEC ISO27001, ISO/IEC 27002:2013, SSAE-18, ISAE3402, National Institute of Standards and Technology (NIST) NIST 800-53, the Open Web Application Security Project (OWASP) Guide to Building Secure Web Applications, and the Center for Internet Security (CIS) Standards (or any successor to these security standards) or any other industry security standards mutually agreed by Parties
• Ability to function as an autonomous project manager for internal CMCF projects but recognize when the involvement of senior management is required
• Working knowledge of regulatory requirements for software and hardware as well as validation and verification requirements
• The position requires a bachelor's degree in a relevant field and at least 5 years of experience in a blood bank or cGMP laboratory, along with 5 years of system experience. Candidates must have knowledge of compliance requirements for PHI, validated systems, and networked computer systems, as well as proficiency in tools such as FileMaker Pro, Microsoft applications (Excel pivot tables, OneDrive, SharePoint, Teams), Rees, Master Control, Eceptionist, BOE/BPAA, Sunquest, EPIC, LIMS, and MES. Familiarity with regulatory standards (21 CFR Part 11 and cGDP) and accreditation requirements for information systems validation and operation is essential. A certificate in project management is desired.

A certificate in project management is desired.