Senior Engineer, IT Computer System Validation (CSV)

Role Summary

The Senior Engineer, IT Computer System Validation (CSV), Cell Therapy Devens role provides support to the Digital Plant team at the Devens Cell Therapy Facility (CTF) by managing computerized system validation (CSV) activities and major projects, and by supporting deviations and change controls related to computerized systems. The role works closely with Digital Plant (IT/Automation) SMEs and stakeholders including Manufacturing Science and Technology (MS&T), Quality Engineering (QE), and Manufacturing Operations.

Responsibilities

• Gain a thorough understanding of computer systems deployed at Devens CTF.
• 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.
• Drive and own the validation lifecycle documentation for newly implemented computerized systems.
• Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects.
• 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 Infinity (Quality Management System) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness reviews as needed.
• Interact with ServiceNow to review and approve digital changes.
• Provide quality support of Digital Plant programs and system maintenance activities.
• Responsible for routine completion of quality events, quality actions, risk assessments, and other compliance documentation associated to computerized systems.
• Ability to support on-call deviations on a rotational basis.
• Perform project audits as the needs arise.
• Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated as it pertains to CSV responsibilities.

Qualifications

• Required: A BS in science, engineering, biochemistry or related discipline, or its equivalent.
• 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.
• Required: Knowledge of CSV principles, GAMP 5 concepts, FDA 21 CFR Part 11, and data integrity.
• Preferred: Knowledge of various Manufacturing IT systems such as Process Automation System (DeltaV), Manufacturing Execution Systems (Syncade), Data Historians (OSI PI), Enterprise Resource Planning (SAP), and Laboratory Information Management System (Celabs).
• Preferred: Knowledge of various GxP supporting systems, such as Quality Management System (Infinity) and Document Management Systems (CelDox).
• Preferred: Knowledge of paperless validation systems, such as ValGenesis.
• Preferred: Project Management experience around manufacturing automation systems.
• Preferred: Experience working in a team-based environment with a diverse group of people.
• Preferred: Experience managing multiple large projects and staffing resources accordingly.
• Required: High quality assurance mindset with QA experience in the computer system and pharmaceutical computerized systems field and understanding of quality risk management principles.
• Required: Understanding of SOPs, cGMPs and other compliance requirements including guidelines within a regulatory environment (FDA, EU).
• Required: Proficiency in project management, oral communication, and technical writing skills.

Skills

• Project management, oral communication, and technical writing.
• Quality assurance mindset with experience in computer systems and pharmaceutical computerized systems; understanding of quality risk management principles.
• Ability to work in a team-based environment with a diverse group of people.
• Ability to manage multiple large projects and staffing resources accordingly.
• Strong understanding of SOPs, cGMPs, and regulatory guidelines (FDA, EU).

Education

• B.S. in science, engineering, biochemistry or related discipline, or equivalent.