Specialist, Qa Engineering

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.
The Specialist is responsible for providing quality oversight for Site Validation activities and Quality Control Laboratory method and equipment validation in accordance with BMS policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment, laboratory, and facility activities; support data integrity initiatives for the site.
Shift Available:

• Monday - Friday, Hybrid (50% onsite minimum), 8 a.m. - 5 p.m.

Responsibilities:

• Supports all activities for the Quality Engineering group.
• Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
• Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
• Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
• Review media simulation activities to ensure successful execution and documentation.
• Ensure site is compliant with global and regulatory data governance and data integrity requirements.
• Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
• Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.
• Ensure method qualifications, method transfers, and analyst trainings meet company and regulatory requirements.

Knowledge & Skills:

• Must have GMP, Quality, and in-depth risk management knowledge.
• Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
• Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
• Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
• Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
• Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
• Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions.
• Recognizes risk and develops contingency plans.
• Negotiates solutions cross-functionally.
• Drives continuous improvement and improves efficiency and productivity within the group or project.

Basic Requirements:

• Bachelor of Science degree required.
• 1 year experience with Laboratory or Equipment Validation experience is required.
• 1 year prior cGMP experience required.
• 1 year prior QA experience required.

Working Conditions:

• 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 10% of the time.
• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

BMSCART, #LI-Hybrid
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.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments 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 cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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.