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Process Robustness Lead Engineer

4 months ago

Devens, Massachusetts, United States Bristol Myers Squibb Full time
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: .

The Engineer in the Biologics Robustness and Data Systems (BRDS ) group within Manufacturing Sciences & Technology will be responsible for product robustness of the commercial products manufactured in BMS and contract manufacturing organizations (CMO). The PMA team provides advanced data analysis and reporting to ensure robust manufacturing process and product quality. The team is responsible for the implementation and maintenance of procedures, systems, and business processes related to Continued Process Verification and product robustness programs across the BMS network (internal and CMO sites). The candidate will interact with the different parts of the Global Product Development and Supply organization at the network and site-level.

Key Responsibilities:
  • Provides support to maintain the Statistical Process Control (SPC) program, manufacturing performance trending and reporting.
  • Manage and support investigations as a result of robustness events and SPC trending
  • Provides system administration/maintenance of the data trending electronic systems.
  • Manage and support data inquiries from regulatory agencies and matrix teams using data systems (LIMS, Discoverant, Datalake)
  • Provides data and analysis for regulatory inspections and other interactions with regulatory agencies as required.
  • Demonstrates a strong knowledge of cGMP compliance, regulatory agency requirements and procedures and incorporate into all assigned projects.
  • Manages the implementation of process or equipment changes as a result of the SPC program.
  • Support the development of dashboards and automated reporting capabilities for process and product robustness
  • Provide statistical analysis on complex datasets using statistical packages (JMP, Minitab) and/or coding (R/Python)
  • Partner with laboratory groups and MT to build capability using new technologies (e.g Umetrics, and PAT) to gather and analyze process data to drive yield improvements and process robustness
Qualifications & Experience:
  • Knowledge of SOPs, cGMPs and the knowhow to work and manage within a regulatory environment
  • Knowledge of pharmaceutical facility design, process design and optimization, and manufacturing operations
  • Knowledge of aseptic fill finish, sterile manufacturing, and parenteral packaging.
  • Excellent verbal & written communications skills.
  • Interpersonal/facilitation skills necessary to interface with and influence all levels of the organization.
  • Demonstrated ability to take initiative, prioritize objectives from multiple projects, and to adhere to scheduled timelines while maintaining flexibility
  • Proven leadership skills with ability to direct and influence a team
  • Demonstrated problem solving ability, attention to detail, and analytical thinking
  • Experience in statistical analysis is highly desired
  • Experience with the use of and scripting in different software packages like SAS, JMP, Minitab, Spotfire, Umetrics SIMCA, and Discoverant is an advantage. Experience with data management systems and data networks is preferred.
  • Experience with data analytics and the use of statistical programming languages like R, Python, SAS is preferred
Education/ Licenses/Certifications:
  • Minimum BS or equivalent with 5 years BMS/ relevant experience,
  • MS or equivalent with 2 years BMS/ relevant experience,
  • Ph.D. level in Scientific or Mathematical discipline with 0-1 years of relevant experience.
Travel:

This position requires up to 10% of travel

#LI-ONSITE #BMSBDLMA

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 scienceTM , 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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit 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.