Specialist, Validation Engineer (R1557697-en-us)
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.
- Executes with guidance from validation leads or management validation efforts associated with the operation of GMP manufacturing systems including installation, operational and performance qualification (IQ/OQ/PQ) of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.
- Execution of testing of required changes to the site Process Automation System (Delta V) - - Execution of testing of process recipes for the Manufacturing Execution System (Syncade)
- Performs assessment of validation work arising from change controls, capital projects, shutdown/changeover activity and ongoing revalidation programs with support from department management Technical work assignments and interfaces with project stakeholders. - - - Maintains familiarity with BMS directives and industry guidelines on qualification/validation.
-Provides, in addition to operations support, internal compliance and/or efficiency improvement efforts within department for less complex processes.
Knowledge & Skills
- Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical or mechanical preferred), a related discipline, or its equivalent. Co-op or internship experience in biopharmaceutical industry including experience with manufacturing equipment support in the Biotechnology manufacturing industry is desired.
- Familiarity with or interest in process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping concepts is desired.
- Familiarity with or interest in distributed control systems and automation (GAMP) validation concepts may enable this individual to participate in cross-functional validation efforts. - Excellent project management, communication, and technical writing skills are required. - -- Demonstrate effectiveness in both a team environment and an individual contributor role.
- 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 on occasion to properly use Personal Protective Equipment (PPE).
- Exercises sound judgment in making decisions and recommendations within generally defined practices and policies with management supervision.
- Typically makes recommendations to Manager, but does not make final decisions.
- May work 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.
- Becomes actively involved as required to meet schedules or resolve problems. Erroneous decisions or failure to achieve results may have financial implications or cause delays in schedules.
- Incumbent performs all standard procedurally defined tasks completely and independently. - Works at the direction of Validation Engineer, Sr. Validation Engineer or Manager to determine methods and procedures for novel assignments.
- Receives assignments in the form of objectives and establishes goals to meet objectives. - Work is reviewed and measured based on meeting established objectives and schedules.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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