Senior Parenteral Inspection Technology Specialist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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):

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com