Specialist, Aseptic Manufacturing
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 Specialist is responsible for supporting/leading all aspects of Aseptic Manufacturing department related technical needs and serves as a liaison to other departments as needed in support of projects, document changes, and investigations. The Specialist will support/lead training, deviations, change controls, standard operating procedures, protocols, complaints and policies ensuring appropriate resources are available to meet production needs.
Required Competencies: Knowledge, Skills, and Abilities
- Intermediate proficiency in MS Office Suite applications.
- Intermediate knowledge of cGMP for a controlled manufacturing area.
- Intermediate critical thinking and decision making skills.
- Intermediate time-management, organizational, and multi-tasking abilities.
- Intermediate written and verbal communication skills.
- Basic trending analysis skills to include compilation, sorting and reporting.
- Basic understanding of Validation concepts and principles.
- Ability to solve routine and moderately complex problems.
- Ability to interpret / write technical documents.
- Ability to work independently for extended periods of time.
- Ability to work within or lead a cross-functional team to support site/departments projects.
Duties and Responsibilities
- Change Control
- SOP revision/creation Works with Aseptic Manufacturing Management to ensure compliance with cGMPs, SOPs and policies.
- Collaborates with Aseptic Manufacturing Management to support/lead initiatives to improve the manufacturing process.
- Lead cross functional investigative teams deploying specific investigative principles as necessary to ensure root cause analysis and corrective action(s) o Ensures corrective actions and improvements are shared and incorporated into the appropriate process.
- Provides feedback to Aseptic Manufacturing Management and support groups in relation to findings during deviation investigations. The Official Copy is the electronic file. Verify document is the Approved version before proceeding.
- Generate, manage and execute CAPA and Change Control documents to support response to deviations, audit findings and independent corrective actions.
- Generate and execute change notice to support SOP, Work Practice and Program revision and maintenance.
- Compile department and site trending information for evaluation.
- Participate in the development, implementation, and maintenance of department/site programs. Performs all other tasks as assigned.
Education and Experience
- Relevant college or university degree preferred.
- 5 years relevant work experience required, preferably in a pharmaceutical environment.
- An equivalent combination of education and experience acceptable.
- Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 20% of the time.
- Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
- The incumbent must be able effectively communicate deviation/investigation results to the senior leadership within the site on a weekly basis.
- The incumbent must be able to gown to Grade A, B, C and D requirements. This requires the ability to bend and move to gown aseptically.
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.
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.
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 email@example.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.