OPERATIONS PROCESS SUPPORT SPECIALIST

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.

Provides operational, scientific expertise and compliance knowledge support to the Manufacturing Sterile Operations. Responsible for executing manufacturing investigations (QE’s), Corrective Action Preventive Action (CAPA’s), procedures development & revision, and process validation documentation. Acts as facilitator for the necessary information related to the support of the existing processes, the fast tracking for documenting, implementing process modifications and technology for products transfers and validation. This incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job functions.

MAJOR DUTIES AND RESPONSIBILITIES :
  • Ensures that all QE’s and CAPA’s are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
  • Reviews and provides input to regulatory submissions applicable to area of responsibility. Leads QE’s and trend evaluation.
  • Participates in the new product introduction process to determine requirements for documentation, materials, training and equipment modifications.
  • Supports establishment of process monitoring parameters and control limits.
  • Supports the assessment of deviations and process monitoring data Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality.
  • Provides technical assistance to identify, recommend and implement process and equipment modifications to improve process performance to identify and assist in the implementation of cost reduction projects and assuring the manufacturing area is in cGMP’s compliance.
  • Write, evaluate, and revise the required manufacturing documentation (i.e. SOP’s, MBR’s, etc.) and may assist in providing training on scientific or technical aspects of the processes.
  • Assists with generation and execution of validation protocols and reports.
  • Participates in regulatory inspection when necessary.
  • Assists the area managers and supervisory personnel to solve any production technical problem (i.e. Process / equipment troubleshooting, yield, cycle time, quality and productivity).
  • Provides alternatives and recommendations to improve and maximize processes and equipment.
  • Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation. Promotes and model the BMS Core Behaviors, facilitating teamwork.
  • Supports all site Initiatives and any other assignments based on business needs.


KNOWLEDGE & SKILLS:
  • BS Degree in Science, Pharmacy and/or Engineering
  • Five (5) years of experience in a Parenteral Manufacturing facility.
  • Strong technical writing and presentation skills
  • Ability to interpret and analyze statistical data.
  • Knowledge in CGMP’s, OSHA, EPA and other regulatory standards
  • Knowledge of computers applications (Microsoft Word, Excel, Power Point)
  • Excellent interpersonal skills and team work oriented
  • Excellent communications skills in Spanish /English


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.

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

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

R1548804-en-us