Group Leader-Parenteral Manufacturing

Profile

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.

Summary:

To assist the area supervisor in the coordination, and execution of daily administrative activities in the manufacturing processing and finishing areas to assure compliance with production plans, current Good Manufacturing Practice, company standards and budget objectives. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Responsibilities:


Assists supervisor with the daily coordination of manufacturing activities:



reviewing shift personnel vs. capacity requirements to run the manufacturing / finishing process as per the scheduled plan.
In the completion of comments or corrections requested by QA.
In monitoring the production and supporting changes to guarantee minimum loss of capacity.
In the coordination of line equipment set up and changeover, cleaning procedures (areas / equipment), set up crew activities and housekeeping compliance.
In monitoring the manufacturing process to prevent process deviations.
In providing daily status on production activity, downtime, and in reporting any equipment malfunctions to the production and maintenance supervisor.2. Reviews area documentation to ensure it is complete, accurate, error free, and on time delivery and; writes and reviews change controls, operational and safety SOP's, log books and others documentation.3. Coordinates the area personnel participation in regulatory trainings such as cGMPs, EHS, etc.4. Originates work orders, document revision, Quality Events, SAP transactions, etc. and keeps the inventory of operational supplies.Provides support in other activities:
during the external and regulatory audits.
area deviation investigations
to the Annual Requalification Program by assuring plan execution on established timeframe.
to the Environmental Monitoring Program by providing necessary personnel.
to manufacturing activities in other operation areas, as required5. Performs as the backup for Manufacturing Technician and Sr. Manufacturing Technicians responsibilities when necessary.Knowledge/Education/Experience:
Associate Degree in a technical field with Ten (10) years of experience in a pharmaceutical manufacturing industry and at least Five (5) years of experience within a parenteral manufacturing operation.
Bachelor Degree in Science ,Administration or Engineering with Seven (7) years of experience in a pharmaceutical manufacturing industry and at least Three (3) years of experience within a parenteral manufacturing operation.
Excellent leadership characteristics, accountability and commitment.
Good communications, planning, problem solving and interpersonal relations skills
Self starter and able to make decisions of simple situations during manufacturing activities.
Full knowledge of cGMP and EHS practices.
Ability to read and comprehend detailed technical information and directions.
Technical knowledge and experience with automated equipment (computer, or PLC control) for set-up, operation and troubleshoot using the interface systems (HMI, SCADA, etc.)
Good documentation skills.
Effective written and oral communication skills both Spanish and English
Willing to work irregular hours, rotation shifts, weekends and holidays
Willing to work irregular hours, rotation shifts, weekends and holidaysAround 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. Company: Bristol-Myers Squibb Req Number: R1526749_EN Updated: 2020-07-01 00:00:00.000 UTC Location: Manati, PR


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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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