Validation Scientist Engineer

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.

Reporting to the Validation Manager, this Validation staff member will coordinate with Production, Quality, engineering, and other personnel as needed to manage projects and process improvements. The Validation Scientist / Engineer will be responsible to plan, manage, and execute the start-up, commissioning, and validation of new equipment, assist in the creation of validation assessments and validation master/project plans, for the following but not limited to: Equipment and utilities system qualifications, temperature mapping validations and facilities qualifications. The Validation Scientist / Engineer may lead and/or coach junior scientist and contractor during daily qualification activities when required.

Responsibilities:

• Write protocols, perform field executions, and complete final reports for Equipment/utilities/facilities system qualifications, including temperature mapping studies, utility sampling, steaming of process equipment and autoclaves.
• Investigate process and quality problems and implement corrective actions
• Identify and define project and process improvement opportunities and support process improvement projects
• Develop project plans and timelines
• Track project schedules and milestones
• Work within cross functional teams
• Communicate progress effectively
• Ensure process and project documentation is accurate and updated
• Maintain safe working environment
• Follow company policies and procedures
• Operate equipment to perform operational qualifications and thermal mapping.
• Record/review data using good documentation practices.
• Conduct investigations as required.
• Support Validation Services activities by writing and revising SOPs, training materials and change requests.
• As a Validation Subject Mater Expert (SME) participated in both regulatory and internal inspections and ensures the timely correction of any outstanding items as a result of inspections.
• Evaluate and assess change controls request, and make recommendation following validation services SOPs.
• Serve as Validation Services designee as directed when training and qualifications are appropriate.
• Support validation department activities to maintain proper documentation storage and database system.

QUALIFICATIONS

BS degree in Engineering, Chemistry, or the Biological Sciences relevant experience with 2 to 3 years of direct validation experience and biopharmaceutical/pharmaceutical experience. Direct experience or close familiarity with equipment/utility/facility qualifications and general validation practices is desired. A working understanding of lean principles is a plus. Excellent project management, communication, and technical writing skills are required. The Validation engineer will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management. Experience with GMP and/or regulatory inspections and audits.

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.