Principal Process Improver

Location
Manati, PR, United States
Posted
Sep 22, 2020
Ref
R1529425
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 project management, process improvements, 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

1. 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.

2. Reviews and provides input to regulatory submissions applicable to area of responsibility. 3. Leads investigation task items, CAPA's Change Controls and Stand Alone trend evaluation. 4. Acts as core team member in the new product introduction process to determine requirements for documentation, materials, training, equipment / process modifications, and document revisions.

5. 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.

6. Develops and maintains effective working relationships with other division groups in support of process improvements activities.

7. Leads, motivates, mentors and provides technical leadership to junior process improvers, and develops team members to meet and exceed plant and company goals and objectives.

8. May represent the site and lead site Process Improvement Team to assure timely delivery of targets.

9. Supports establishment of process monitoring parameters and control limits.

9. Supports the assessment of deviations and process monitoring data.

11. Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality.

12. 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.

13. 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.

14. Assists with generation and execution of validation protocols and reports.

15. Participates in regulatory inspection when necessary.

16. Leads the development and execution of CAPA's and Stand Alones including identifying response plan, execution and revision of associated documentation.

17. 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.

18. Assists the area leads and supervisory personnel to solve any production technical problem (i.e. Process / equipment troubleshooting, yield, cycle time, quality and productivity). 19. Provides alternatives and recommendations to improve and maximize processes and equipment.

20. Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation.

21. Promotes and models the BMS Core Behaviors, facilitating teamwork.

22. Supports all site initiatives and any other assignments based on business needs.

23. Leads, coordinates and facilitates Process Improvement area activities in alignment with business needs.

24. Performs as back up in the absence of the Associate Director Process Improvement as needed.

DECISION MAKING
  • 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 action to assure the manufacturing area is in cGMP's compliance.
  • Responsibility of identifying, recommend and implement process and/or equipment modifications to improve process performance and maximize processes and equipment
  • Decisions taken in support of existing manufacturing processes can often lead to cost avoidance or cost improvement.


CONTACTS
  • Daily contact with site peers, management and staff to lead, set and / or follow priorities driven by business needs.
  • Regular communication with multidisciplinary teams to assure accurate planning and execution of change controls, CAPAs and Projects for new/existing manufacturing processes.
  • Frequent interactions with site QC / QA, Manufacturing, Materials Control, EHS, Engineering, Operational Excellence, Finance and Supply Chain management for the support of new/existing manufacturing operations.
  • 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, Chemistry and/or Engineering
  • Seven (7) years of experience in a Parenteral Manufacturing operation facility
  • Three (3) years of experience in parenteral manufacturing process support and improvement strongly preferred
  • Excellent organizational skills and ability to manage a multitude of activities/projects.
  • 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
  • Demonstrated lead management, interpersonal and teamwork skills. Strong mentor, with excellent people development skills and track record.
  • Outstanding communication skills, both Spanish /English (oral/written)
  • Strong project management skills and experiences.
  • Engineering principles aptitude
  • Ability to effectively lead a cross functional site teams towards execution of technical transfer activities.
  • Ability to work in a fast paced, complex and changing environment.
  • Ability to manage personnel and financial resources.
  • Strong knowledge and practical experience in manufacturing processes, technologies and processing equipment, CGMP's and FDA regulations and trends.
  • Excellent analytical and strategic thinking skills and experiences.


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.