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Systems Administrator - Cell Manufacturing Core Facilities

Dana-Farber-Partners Cancercare Network

Boston, MA | Full Time

$90k-115k (estimate)

3 Weeks Ago

Systems Administrator - Cell Manufacturing Core Facilities

$90k-115k (estimate)

Full Time 3 Weeks Ago

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Dana-Farber-Partners Cancercare Network is Hiring a Systems Administrator - Cell Manufacturing Core Facilities Near Boston, MA

Job ID: 2024-39890Category: IT/Health IT/InformaticsType: full timeGrade: 1Location : Address: 450 Brookline AveLocation : City: Boston

Overview

The System Administrator II will work internal to the Cell Manipulation Core Facility to help support and manage systems across the Cell Therapy (CT) Networks by implementation and validation of computer systems impacting the department and CT program.

The System Administrator II 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.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Responsibilities

Business and Operational Needs:

Examines existing business models and flows of data in CT and helps to implement and support the IT manufacturing solutions for the CMCF.

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.

Assists in the compilation of relevant data as required for ongoing analyses and quality improvement.

Assists in the implementation of and 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 appropriate database for analysis of quality assurance indicators, as required for FACT, accreditation bodies, sponsors and for individual protocols, etc.

Systems:

Participates in 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, 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.

Project Management Skills:

Works with Partners project teams to help develop work plans and timelines for new application/system implementations as well as upgrades.

Facilitates group projects towards a 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.

Training & Development:

Aids in development of training plans and materials for various applications as well as conduct end user trainings.

Performs super-user and end-user training of applications and support 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.

System Quality Assurance and Regulatory Compliance:

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 brings 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.

Manages the authorization and security functions of select systems.

Collaborations:

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.

WORK SCHEDULE: Office environment. Heavy P.C. usage, Involvement in 24x7 support rotation. May need to spend time in the CMCF lab to fully understand the design requirements and to troubleshoot equipment, interfaces and facility needs.

SUPERVISORY RESPONSIBILITIES: May provide supervision to junior members.

PATIENT CONTACT: None

Qualifications

Minimum Education:Bachelor's degree in a relevant field required.

Minimum Experience:5 years of relevant experience in a blood bank or cGMP laboratory and 2 years of system experience required. Working knowledge of compliance requirements when dealing with PHI, validated systems and networked computer systems. Working knowledge of FileMaker Pro, Microsoft applications (MS Excel pivot tables, OneDrive, SharePoint, Teams), Rees, Master Control, Eceptionist, BOE/BPAA, Sunquest, EPIC, LIMS, MES.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

Knowledge of lab safety and infection control.
Knowledge of cell therapy processing, medical, hematologic, oncologic and scientific terminology.
Demonstrated knowledge of clinical and laboratory workflow to be able to incorporate into design and implementation of CMCF applications.
Working knowledge of flow of data and data structure through complex IT architecture systems.
Knowledge of regulatory (21 CFR part 11 and cGDP) and accreditation requirements regarding validation and operation of information systems.
Working knowledge of regulatory requirements for software and hardware as well as validation and verification requirements.
Knowledge of Web publishing, ODBC/JDBC interfaces and SQL. Knowledge of BOE template builder and ability to collaborate/train on the builder.
Ability to compile data and analyze using basic statistical tools and prepare reports for quality analysis.
Strong analytical, problem-solving skills and project management skills.
Demonstrated competence in managing system projects and in writing and executing validation plans.
Ability to assess workload and prioritize / delegate tasks.
Able to create and validate applications for databases and pivot tables for spreadsheets.
Able to assist vendors working with Partners IT in managing Network servers.
Able to perform basic system scripting, programming and generate reports critical to department operations and compliance.
Ability to 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.
Ability to effectively interact independently; facilitate decision making with users and administrative leadership in multiple venues and environments.
Excellent customer service skills and demonstrated ability to develop effective internal working relationships with a diverse employee population.
Ability to follow industry qualifications standards for the design (DQ), implementation (IQ), operational (OQ) and performance (OQ) testing and documentation.
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 understand the enterprise environment and competing priorities in conjunction with developing/meeting project goals.
Ability to follow established procedures.
Adheres to all applicable DFCI policies including safety, HPAA and Code of Conduct.
Ability to continually upgrade job skills.
Ability to accommodate schedule adjustments, as well as off-shift and weekend assignments as workload dictates.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

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