Senior Engineer - It Compliance, Cell Therapy Devens

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The Senior Engineer - IT Compliance, Cell Therapy Devens role will provide support to the Digital Plant team at the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change controls 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 (MS&T), Quality Engineering (QE), and Manufacturing Operations.
Major Duties & Job 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.
• 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.
• 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 needed.
• 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 Quality & Compliance staff and provide guidance as necessary.

Knowledge & Skills

• 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 preferred, not required.
• Experience working in a team-based environment with a diverse group of people.
• Experience managing multiple large projects and staffing resources accordingly.
• High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and understanding of quality risk management principles.
• Understanding of SOPs, cGMPs and other compliance requirements including guidelines within a regulatory environment (FDA, EU).
• Proficiency in project management, oral communication, and technical writing skills are required.

Decision Making

• Exercises sound judgment in making decisions and recommendations. Routinely makes decisions and takes or influences action on typical and atypical cases. Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Erroneous decisions or failure to achieve results will have significant financial implications, compliance implications or cause significant delays in schedules.
• Coordinates with higher level IT Quality personnel on decisions and applies appropriate notification to management as appropriate.

Supervision Received

• Incumbent typically manages a complete function or process, either through staff, the coordination of a team, or individual efforts. Receives assignments in the form of objectives and establishes goals to meet objectives. Work is measured based on meeting established objectives and schedules.
• Receives assignments which require the application of a defined process to complete the assignment. As such, specific assignments are allocated based upon the recipient's demonstrated capabilities with the degree of supervisory attention determined accordingly.

Contacts

• Work both independently and in a team environment at all levels of the organization, in particular Digital Plant, MS&T, Validation, Quality and Manufacturing Operations.

Working Conditions

• Work within Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site initiatives to drive policy.

#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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