E-Systems Validation Specialist

Immunogen, Inc. Waltham , MA 02154

Posted 2 months ago


Reporting to the E-system Validation and Compliance Manager, the E-Systems Validation Specialist will oversee the validated state of ImmunoGen's GxP computer systems (Veeva, TrackWise, SLIMStat, etc.) to ensure compliance with Code of Federal Regulations (CFR) 21 Part 11, and EU regulations regarding validation of electronic records and electronic signatures. In addition, the E-Systems Validation Specialist will work with third party vendors to develop CSV documentation and ensure timely deployment of new or updated systems.


Essential Duties and Responsibilities:
Develop, update, review, approve and maintain qualification test protocols (IQ, OQ and PQ) and data migration protocols.

Work with internal and external IT teams, business owners and system owners to develop requirements specifications (URS, FRS and SDS) for GxP systems used by IMGN. Develop and maintain Master Validation Plan (MVP) and Validation Plan (including data migration plan) for E-systems. Develop, update, review, approve and maintain summary reports and requirement traceability matrix.

Review planned and unplanned changes (configuration updates, system enhancements, operating system updates, application updates, etc.) and assess validation impact. Perform risk assessment of proposed changes to determine scope of validation/re-validation. Own change control tasks related to system validation and execute them in timely manner.

Coordinate and/or perform test execution of qualification test protocols as necessary. Work with technical and business teams to troubleshoot technical issues encountered during test execution and/or during daily operation of the system. Develop, maintain, and execute E-system periodic review plan to ensure validated electronic systems remain in compliance with appropriate IT and Quality procedures (change control, backup & recovery access control). Participate in the continuous improvements of CVS policies and procedures by providing independent review of the existing documentation.

Help select/manage applicable vendors to ensure completion of deliverables identified in the vendor contract/SOW. Participate in vendor audits to ensure system used by ImmunoGen's GxP vendors meet FDA regulation and industry validation standards. Serve as a backup system administrator (user, report, and configuration management) for selected computer systems.


Education and/or Work Experience Requirements:
Bachelor's Degree in life sciences, engineering, or IT/Computer Science. 5 -7 years' experience in a regulated (pharmaceutical/medical device industry) environment with expertise in the IT System Development Lifecycle.

Ideal candidate brings Veeva and TrackWise validation experience with relevant 21 CFR Part 11 & 211, ICH E6(R2) & ICH Q9, and EudraLex Annex-11 experience. Demonstrated experience and excellent knowledge of applicable CSV and other applicable regulations GAMP guidance. Working knowledge of Project Management and Software Development Life Cycles to be able to coordinate and manage multiple CSV projects.

Familiarity with computer infrastructure, servers, workstations, operating systems, and database management systems. Be able to work with remote teams in multiple geographical locations. Personal Characteristics:

Results Oriented: Establishes clear goals and expectations and effectively allocates resources. Consistently delivers.

Has flexible and creative problem-solving skills. Strategic Thinker: Is able to see the big picture and understand the challenging and sometimes conflicting needs within an organization.

Thinks logically, develops and evaluates options, and identifies pros and cons. Constantly strives for ways to add value and improve how work is done. Team Leader:

Able to manage and lead a group of diverse individuals and assess and nurture talent. Encourages team to present and debate their best ideas and holds the team accountable for results. Communications: Strong, clear communicator who recognizes that new ideas and approaches require a great deal of communication.

Able to communicate across functions and bring people together around a common goal. Self-directed: Able to work effectively with limited direction in a complex, fast paced environment.

Positive Energy: Brings energy into the room and is a strong collaborator. Innovation: Drives and supports new ways of thinking and embraces change.

Patient Focus: Work with urgency and go the extra mile. The patient is waiting.

Physical Requirements: Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. Must be able to lift and carry up to 10 lbs.

Must be able to talk, listen and speak clearly on telephone. Must be able to work in front of computers for longer periods.

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E-Systems Validation Specialist

Immunogen, Inc.