Bristol Myers Squibb Company

Process Improver

Location
Manati, PR, United States
Posted
Aug 25, 2020
Ref
R1528886
Required Education
Bachelors Degree
Position Type
Full time
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

Accountable for providing operational, scientific, and compliance support to Warehouse, Sterile and Non Sterile Manufacturing Operations. Also accountable for the execution and completion of investigation task items, Corrective Action Preventive Action (CAPA's), Stand Alone and Change Controls. 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 investigation task items, Change Controls/Change Actions, CAPA's and Stand Alone Actions 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 investigation task items, CAPA's Change Controls and Stand Alone trend evaluation. Participates in the new product introduction process to determine requirements for documentation, materials, training, equipment / process modifications, and document revisions. Facilitates the necessary information related to the support of the existing processes or systems, the fast tracking for documenting, implementing process modifications and technology for products transfers and validation. 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. Writes, evaluates and revises 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. Leads the development and execution of CAPA's and Stand Alones including identifying response plan, execution and revision of associated documentation. Generates and executes completion of Change Controls related to manufacturing processes/systems/improvements; procedures development & revision, process validation documentation and execute Change Actions from area-related Change Controls. Assists the area leads 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 models the BMS Core Behaviors, facilitating teamwork. Supports all site initiatives and any other assignments based on business needs.
  • The incumbent is responsible for the day-to-day decision making on technical matters related to troubleshooting, manufacturing investigations task items, CAPA's, Change Controls, Stand Alone Actions.
  • Takes immediate action and necessary decisions on manufacturing situations
  • Responsibility of identifying, recommend and implement process and equipment modifications to improve process performance and maximize processes and equipment
  • Decisions may have impact on compliance and cost initiatives
  • Takes action to assure the manufacturing area is in cGMP's compliance
  • Working relationship with unit's members and unit Teams from other disciplines (Engineering/Maintenance, MS&T, QA/QC, TS, SC, etc.). Also works with minimum supervision, with periodic monitoring and review of results.
  • Daily contact with site peers, management and staff to set and / or follow priorities driven by business needs.
  • Regular interaction with internal / external auditors, government agencies, and other regulatory agencies or institutions.
  • Works closely with Warehouse, Sterile and Non Sterile Operations Area Lead / Supervisors to improve current processes in order to optimize product efficiency/yields.
  • KNOWLEDGE / SKILL
  • BS Degree in Science, Pharmacy and/or Engineering
  • Five (5) years of experience in a Parenteral Manufacturing operation facility
  • Broad working experience with Change Controls/Change actions and CAPA
  • Experience with validation protocols
  • 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 leadership and interpersonal skills
  • Team work oriented
  • Excellent communications skills in Spanish /English


WORKING CONDITIONS

A. Describe exposure to any hazards / disagreeable conditions in the work environment:
  • Exposed to various working environments that may potentially expose the incumbent, for which protective equipment is required.


B. Travel required ( describe nature and frequency ):
  • Some travel required to attend meetings and trainings

C. Overnight absences required ( per typical month ):
  • As required.


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.