Bristol-Myers Squibb Company
Devens, MA, United States
Dec 23, 2020
Apr 07, 2021
Bristol Myers Squibb
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.
Knowledge and Skill
Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience
A minimum of 4 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
Knowledge of process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping is preferred.
Experience in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics manufacturing facility.
Knowledge in establishing site and program validation strategies that are aligned with current industry mindsets.
Understanding of lean principles and establishment of effective process metrics is preferred.
Project management, communication, and technical writing skills are required.
Possess the professionalism and technical competency required to represent the department before our stakeholders, and management.
Understanding of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.
Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.
Major Duties and Responsibilities
Responsible for implementing the design, implementation and maintenance of a robust validation lifecycle for process equipment, SIP/CIP processes, critical process equipment & utility systems, and laboratory instrumentation.
Implement validation philosophies and master plans required to drive the validation lifecycle of a fully automated biologics manufacturing facility.
Responsibilities include oversight of validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs.
Responsible to contribute in the preparation for regulatory inspection readiness.
Work collaboratively with peers within Validation, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
Ensure alignment with BMS directives and industry guidelines Execute validation plans arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs.
This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies. Represents Validation in multi-function teams
Work both independently and in a team environment at all levels of the organization, in particular Quality, Engineering and Manufacturing Operations.
Work within all Site Facilities, including laboratory settings, which requires one to give a high attention to detail and to properly use Personal Protective Equipment (PPE).
Exercises sound judgment in making decisions and recommendations within generally defined practices and policies with little guidance, notifying management when necessary. May work on assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Becomes actively involved as required to meet schedules or resolve problems.
The above statements are intended to describe the general nature of work being performed by people assigned to these roles. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.
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.
Bristol Myers Squibb
2020-12-24 02:34:06.804 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Bristol-Myers Squibb Company
Website : http://www.bms.com