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PRINCIPAL OBJECTIVE OF POSITION Describe the purpose of this position:
Responsible for Lyophilization Manufacturing (Parenteral Area) equipments corrective, preventive and predictive Maintenance Program in a timely manner. Take preventive and/or predictive measures to assure proper functioning of operational equipments ensuring compliance with Company standard, regulatory requirements, Standard Operating Procedures (SOP's) and Safety Policies for the Manatí site. 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: State the most important activities and accountabilities of this position. Describe how these activities and accountabilities can influence the achievement of departmental or business goals. ( Attach additional sheets if needed ):
1- Performs corrective, preventive, and predictive maintenance for Lyophilization Manufacturing equipments.
2-Performs problem-solving and troubleshooting on the Lyophilization Manufacturing equipments.
3-Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses.Interacts with computer controlled equipment and processes.
4- Follows the job plans, document and complete corrective, preventive, predictive documentation legible, error free and on time following good documentation practices through the computerized system (MAXIMO).
5- Revises and improve predictive and preventive job plans for the Lyophilization Manufacturing equipments based on observations and experiences.
6- Assures Lyophilization Manufacturing equipments spare parts inventory.
7- Follows ODS (Ozone Depleting Substances) program on how to handle refrigerants.
8- Attends to all mandatory training meetings for cGMP's, EHS and Company Policies.
9- Participates, and assists in resolution of quality investigations.Reconcile data and prepare computerized documents to provide support to quality investigations or similar documents as required.
10-Assists in "on the job training" for new employees.
11- Maintains housekeeping within controls and aseptic environments, according to procedures.
12- Handles Hazardous and Non hazardous waste according to EHS procedures.
13- Participates in special projects and during audits and regulatory inspections as required. 14- Participates and assists in Parenteral Operations validation and qualification activities. 15- Supports Environmental Monitoring Program by assuring samples collection on established timeframe.
16- Supports Annual Requalification Program by assuring plan execution on established timeframe.
17- Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to supervision as required.
18- Assists manufacturing activities in other areas within operations as required.
19. Notifies immediate supervisor of any inconsistencies or violations to Company operation procedures and policies.
This is intended to be a general job description and should not be construed as all-inclusive.
KNOWLEDGE/ EDUCATION/ EXPERIENCE:
1- Able to wear sterile gowns, mask, and full face respirators where required.
2- Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary. 3- 3-Heavy work (25-60 pounds) that requires eye - hand coordination and moving about capacity.
4- Requires movements of objects such as lifting, carrying, pushing and pulling. It involves body movements such as handling and fingering.
5- Available to use Full Face Mask, Latex/Nitrile Gloves, and disposable uniforms on a daily basis. Comply with medical surveillance program.
6-Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.
7- Ability to operate pallet jacks, climb ladders and stairs.
8- Capable to use hand, pneumatic and power tools.
9- Ability to:
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.