Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us

Purpose and Scope of Position

The Senior Scientist, Validation, develops qualification / validation approaches (risk/science based) and provides the scientific rationale documented in protocols and summary reports (including conducting research into industry standards/FDA guidelines). Will perform independent execution of validation activities with minimal oversight and perform data analysis. Will participate and own multi-departmental projects and prepare project schedules, lead projects and associated teams, and work with external departments and vendors. Primary responsibilities include: Process Performance Qualification, Continued Process Verification, Media Fill Simulation, Room / Facility Qualification, Visual Inspection Qualification, Continual Improvement Projects, Cleaning Validation, and Validation of Single Use Systems. Serves as a Subject Matter Expert in a specific Process Validation specialty and provides technical recommendations / guidance.

Required Competencies

• Advanced understanding of Validation concepts and requirements.
• Advanced knowledge of cGMP
• Intermediate written and verbal communication skills.
• Intermediate project management skills.
• Ability to work independently and within a team.
• Intermediate proficiency in Microsoft Word, Outlook, Excel, Project, and PowerPoint.
• Advanced knowledge of Validation industry and regulatory requirements.

Duties and Responsibilities

Independently performs Validation document generation and execution activities.

• Develop the qualification approach and provide the scientific rationale, generate validation protocols(all complexity levels)and assist other department members in conducting industry and regulatory research. Write / approve validation protocols.
• Perform protocol execution and validation activities, including collection of samples associated with qualification or ongoing monitoring activities.
• In coordination with Production and Validation management, schedule equipment times, prepare test equipment and assure that testing is completed according to approved validation protocols.
• Conduct training for internal customers on protocols associated with validated equipment, systems, processes, and specifications.
• Perform complex data analysis, including the use of statistics, and prepare written reports/summaries from validation studies.
• Perform Validation exception investigations as required.
• Cross check and verify validation data prepared by others during the peer review process.

Independently execute project and departmental activities.

• Participate in and lead department and site project teams, while managing timelines, resources, and communications specific to individual tasks.
• Generate project schedules and manage qualification activities according to site objectives and timelines. Collaborate with applicable departments to ensure project activities are completed as scheduled.
• Own department SOPs and generate revisions as required.Prepare / manage change controls and provide validation assessments as required.
• Execute CAPA plans, risk assessments, investigations, and root cause analysis.
• Demonstrate intermediate understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
• Defend validation processes and protocols in internal and external audits as a subject matter expert.Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
• Assist in the training and mentorship of less experienced personnel. Perform general administrative and organizational activities.
• Conduct periodic safety inspections of Validation labs and office areas.
• Complete regulatory, site, and department training requirements on a timely basis.

Perform other tasks as assigned.

Education and Experience

• High School Diploma or equivalent required.
• 5 years relevant work experience required, preferably in a regulated environment.
• Bachelor's degree in Science or Engineering preferred.
• 4 years validation experience in a pharmaceutical or related manufacturing environment preferred.
• An equivalent combination of education, experience, and training may substitute.

Working Conditions

• The incumbent will be required to sit at a desk and type/view a monitor for extended periods of time.
• The incumbent will be required to push, pull, reach, balance, and/or lift greater than 25lbs.
• The incumbent may be required to gown to Grade A, B, C and D requirements. This requires the ability to bend and move in order to gown aseptically.
• Ability to pass an initial full physical exam, including a respiratory certification with annual monitoring.
• The incumbent may be required to distinguish colors and possess correctable vision to 20/20. Annual eye exam may be required

#LI-Onsite

VETERAN

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.