Manager, Parenteral Inspection Technology

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.

PRINCIPAL OBJECTIVE OF POSITION

Responsible of providing support to the inspection engineering activities related to new inspection technologies development, inspection product transfer and inspection operational support of Sterile/Biologics products. Responsibilities include the Interaction and support using the BMS standard inspection technology documentation change control system. This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

MAJOR DUTIES AND RESPONSIBILITIES
  • Improves inspection processes, technologies and systems to insure compliance with drug quality and cost specifications.
  • Writes test procedures, inspection machinery specifications, performs line trials and trouble shooting, works with inspection technology machinery vendors, etc.
  • Coordinates inspection process validation and line trial activities with local validation, production, engineering, planning and quality groups as needed.
  • Supports new inspection technology and product transfers.
  • Supports and assess current inspection processes; perform improvement or changes to existing inspection technology processes.
  • Ensures that equipment are capable of handling all current products configuration components and will determine whether it can support proposed changes.
  • Supports, assists and /or justifies inspection technology /operations capital projects help research.
  • Justifies, designs, specifies, purchases, tests, installs and validates any new equipment purchases.
  • Plans, coordinates, and executes projects to assure achievement of site’s departmental and company goals and objectives.
  • Manage project timetables for new and on going projects.
  • Provide project status through the use of project plans, presentations, or written reports.
  • Provides troubleshooting inspection equipment, executing equipment trials and systems with the knowledge to modify and recommend changes to equipments and components as needed.
  • Provides assistance and technical support to inspection projects for products manufactured at the pharmaceutical manufacturing site in Manati, Puerto Rico.
  • Oversight and support the overall inspection certification program; personnel certification, new inspection methodology, inspection test set maintenance and control.


KNOWLEDGE/SKILL
  • Bachelor Degree in Sciences or Engineering
  • Five (5) years in the Pharmaceutical Industry (Parenteral Manufacturing/Packaging Operations)
  • Strong background on Parenteral Inspection and Packaging processes is required with device assembly experience preferred.
  • Understanding of a broad spectrum of packaging materials, structures, components, and related conversion processes, specially packaging components for sterile products.
  • Excellent technical writing/oral communication skills (English/Spanish).
  • Flexible to work extended hours when required.
  • Computer Proficiency: MS Office, MS Project
  • Able to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the project execution.
  • Technical knowledge in pharmaceutical manufacturing processes, technologies and processing equipment - Sterile Packaging, Inspection and Processes.
  • Capability for providing hands-on support for equipment, materials and process troubleshooting.
  • Knowledge of process improvement and troubleshooting
  • Time management, planning and organization capabilities
  • Project management skills
  • Leadership and teamwork skills
  • Knowledge of cGMP's, OSHA and FDA Regulations
  • Problem-solving skills


WORKING CONDITIONS

A. Describe exposure to any hazards/disagreeable in the work environment:
  • Work frequently around mechanical equipment with automated parts.
  • Most exposure to final container products.

B. Travel required (describe nature and frequency):
  • Overnight travels to the vendors, equipment acceptance testing and project meetings are the nature of travel expected.
  • Approximately 10% travel, depending on nature of projects and project schedule.

C. Overnight absences requires (per typical month):

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.

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 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.

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