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Lead Validation Engineer, Cell Therapy Facility (CTF), Devens, Massachusetts

CategoryInformation Management
Job typeFull-Time
CountryUnited States

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Major Duties & Job Responsibilities:
  • Gain a thorough understanding of all computer systems to be deployed to the new Cell Therapy Facility under development at Devens.
  • Lead future validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System, and Data Historian) in the Cell Therapy Facility, including management of changes.
  • Perform SDLC validation planning for this effort to ensure complete, successful end-to-end qualification of the cell therapy process to be supported by the computer systems, including system interfaces and infrastructure usage.
  • Manage the overall validation project effort, including interactions with other BMS entities responsible for related non-site-based computer systems.
  • Liaise with all BMS stakeholders relevant to the validated computerized systems used in the Cell Therapy Facility.
  • Guide internal Devens Digital Plant groups and vendor SMEs in the definition of and development of validation documents, including procedures and training.
  • Apply quality risk management approaches to situations as the needs arise.
  • Ensure that the entire effort is managed in accordance with Devens procedures and BMS Enterprise procedures.
  • Review and approve qualification documents, before and after execution, as required.
  • Potentially manage a group of additional contractors performing qualification activities.
  • Generate and/or supervise the generation of validation reports as needed.
  • Perform project audits as the needs arise.
  • Advise on contractual arrangements with vendors to support the Devens validation process.
  • Ensure that procedural methodologies employed to maintain the validated state are regularly reviewed and updated as needed.
  • Lead validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
  • Develop appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel projects.
  • Provide validation subject matter expertise (SME), to multi-function teams, advises operations on validation matters, and defend their work before regulatory agencies.
  • Ensure alignment with BMS directives and industry guidelines on validation.
  • Duties may include internal compliance or efficiency improvement efforts within department.

Knowledge & Skills
  • Both high-level and detailed knowledge of SDLC approaches (such as GAMP 5) and computer system validation concepts. Ability to interact with all levels in the organization.
  • Good understanding of computer systems used at the Devens site, such as Syncade, DeltaV and PI.
  • Good understanding of the biologics development process.
  • Good understanding of IT infrastructure concepts (networking, firewalls, switches, routers, etc.)
  • Ability to transfer concepts to subordinates. Ability to extract detailed information from technical personnel, and develop coherent and complete plans and reports.
  • Experience with supporting internal and external audits.
  • High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical automation field, and understanding of quality risk management principles.
  • Experience with managing the Computer System Validation of a new facility. Must have ability to assess vendor contracts around CSV strategies and agreements, to leverage vendor commissioning documentation.
  • Specific technical skills with biopharmaceutical processing including a minimum of 6 years' experience in maintaining the compliance status of computerized systems used for process automation, such as Syncade and DeltaV.
  • Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
  • Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
  • Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
  • Comprehensive DCS and PLC based experience, preferably gained in the pharmaceutical industry. Knowledge of procedural batch processing automation in a Delta V environment.
  • Knowledge of a system life cycle validation techniques for automation software specification and development.
  • Experience with dealing with recognized large automation providers (Emerson preferred).
  • Familiarity with distributed control systems and automation (GAMP) validation concepts allows this individual to participate in cross-functional validation efforts.
  • A working understanding of lean principles is a suggested.
  • Demonstrated proficiency in project management, oral communication, and technical writing skills are required.
  • The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

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. Acts as an advisor to subordinates and becomes actively involved to meet schedules or resolve problems. Erroneous decisions or failure to achieve results will have significant financial implications, compliance implications or cause significant delays in schedules.

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. Identifies and resolves any discrepancies from normal practices or procedures to cross-functional team, recommending and implementing corrective actions. Only critical discrepancies are reported to management.

  • Work both independently and in a team environment at all levels of the organization, in particular Quality, Engineering 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.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
EmployerBristol-Myers Squibb

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