Lyophilization Maintenance Technician, Manatí

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 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:

• AA/AS degree in Mechanical, Instrumentation, Electronics and/or Refrigeration Technician course / certification with Refrigeration License, EPA License and "Colegiación Técnico de Refrigeración"
• Three (3) years of experience in a similar (manufacturing / maintenance) position within a pharmaceutical environment.
• Excellent organizational skills and sense of urgency.
• Customer service oriented and self starter.
• Effective written and oral communication skills both Spanish and English.
• Ability to write technically in order to provide support for quality investigations related to the area.
• Ability to generate additional area equipment process reports requested by internal and or external customers.
• Ability to develop and maintain area performance metrics and Statistics.
• Basic knowledge on Computerized, PLC control equipment, procedures and new scientific processes.
• Ability to provide job training, theoretical and or On the Job, for new employees following the Production Maintenance Department Qualification Curriculum.
• Knowledge of all critical process parameters and their impact in product quality.
• Knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization and isolators technology preferable.
• Understanding of Process Equipment set-up according to SOPs.
• Ability to apply critical thinking to resolve complex issues.
• Excellent leadership characteristics, accountability and commitment.
• Team player and collaborating skills.
• Knowledgeable in cGMP's, process area, documentation, safety, EHS and hygiene practices.
• Skill in performing detailed tasks and documenting information.
• Ability to enter data into a computer and perform complex process transactions.
• Skill in accurate visual inspection (e.g. equipment components defects).
• Ability to communicate via multiple channels and with varied audiences ( team members, FDA, EMEA, OSHA, senior leaders).
• Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
• Analytical and mathematical skills appropriate to the function.
• Strong organizational skills.
• Knowledge of basic principles of mechanics.
• Strong knowledge in refrigeration systems.
• Skills in electrical and mechanical troubleshooting.

PHYSICAL DEMANDS:

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:

• Connect cables and plugs.
• Insert shims and bearings.
• Maintain parts, motors, machinery equipment and controls.
• Open parts, motors, machinery, equipment and controls.
• Operate equipment, power tools and instruments.
• Remove bearings and parts.
• Use keyboard on computer or terminal to document preventive maintenance and repairs, enter data and requisition parts.

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.