Senior Engineer, IT Computer System Validation (CSV)

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Summary:

We are seeking a highly skilled and motivated Senior Engineer – IT Computer System Validation (CSV) to join our team at the Devens Cell Therapy Facility (CTF). The Senior CSV Engineer will be responsible for managing the computerized system validation (CSV) activities for major projects to comply with regulatory requirements and industry standards. This role will be focused on development, execution, and maintenance of validation lifecycle documentation and helping support routine run the business operations related to computerized systems.

This position work closely with the Digital Plant (IT/Automation) subject matter experts and other key stakeholders, such as Manufacturing Science and Technology, Quality, Manufacturing Operations, and Validation.

Key Responsibilities:

• Gain a thorough understanding of computer systems deployed at Devens CTF.

• Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for computer systems and software applications used in GxP environments.

• Act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects – advising operations on CSV matters and defending their work before regulatory agencies.

• Day-to-day oversight of the CSV program, ensuring standardization and consistency of qualification testing documents and associated testing deviations, providing escalations to CSV Lead as appropriate.

• Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.

• Participates in regulatory audits as Digital Plant secondary representative and assists in generating responses to audit observations.

• Provides IT quality support to Devens CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and CSV activities.

• Interact with ServiceNow to review and approve digital changes.

• Provide support of Digital Plant programs and system maintenance activities.

• Ability to support on-call deviations on a rotational basis.

• Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects.

• Provide CSV input to multi-function teams, advises operations on CSV matters, and defend their work before regulatory agencies.

• Duties may include internal compliance or efficiency improvement efforts within department.

• Mentor other IT CSV staff and provide guidance as necessary

Qualifications:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.

• A minimum of six (6) years of relevant experience in a regulated environment with at least four (4) years focused on quality assurance, validation, or compliance for computerized systems.

• Knowledge of CSV principles, GAMP 5 concepts, FDA 21 CFR Part 11, and data integrity is required.

• Knowledge of various Manufacturing IT systems such as: Process Automation System (DeltaV), Manufacturing Execution Systems (Syncade), Data Historians (OSI PI), Enterprise Resource Planning (SAP), Laboratory Information Management System (Celabs) is preferred.

• Knowledge of various GxP supporting systems, such as Quality Management System (Infinity) and Document Management Systems (CelDox) is desirable.

• Knowledge of paperless validation systems, such as ValGenesis is preferr