Supervisor, Production Maintenance
Bristol-Myers Squibb Company
Manati - PR - US
hace 20 días

Summary :

To lead and manage all maintenance activities in the Parenteral production areas. These activities include but are not limited to the execution and continuous revision of the reliability centered maintenance program (Job Plans Structure Based in Preventive, Predictive, Proactive and Corrective maintenance), perform work orders and provide daily support to the manufacturing schedules of Parenteral areas (PSA, ParLyo and PVA).

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 Responsibilities :

  • Assures completion of all production maintenance activities (e.g., p.m.’s, pdm’s, work orders, safety inspection, area projects, day-
  • to-day equipment and systems support) for the site by coordinating maintenance services with other operations leaders and planning personnel.

  • Participates in Manufacturing Alignment Teams as the engineering department representative. Supports compliance with production and packaging schedules.
  • Creates, identifies and implements new and innovative ideas / technologies for the successful development of business opportunities.
  • Identifies and implements initiatives to improve business efficiencies.
  • Develops new systems, practices and procedures to enhance the performance of the business.
  • Facilitates change through creative technical solutions that are grounded in a realistic assessment of what can be achieved
  • Ensures documentation of all maintenance activities is completed using MAXIMO Program.
  • Reviews and develops FMEAs or FMECAs, Root Cause Analysis and Maintenance Plans based on reliability for all manufacturing equipment.
  • Reviews and develops required equipment spare parts list to assure minimum equipment repair time.
  • Reports performance metrics (e.g. in a monthly basis such as equipment mean time to repair and mean time to failure) and provide / execute corrective actions plans.
  • Originates Change Control, Quality Events and CAPA related documentation and ensures its early completion.
  • Troubleshoots routine and unusual technical / administrative problems.
  • Ensures that all operations in all areas of responsibility comply with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, EMEA, etc.).
  • Ensures that all areas and the environment where maintenance jobs are performed are audited and in compliance with BMS EHS policies and procedures.
  • Prepares weekly reports (e.g., highlights on area performance, budget, etc.).
  • Authorizes purchases for the parts and services required in the production and packaging areas in accordance to budget.
  • Supervises technicians assigned to the production maintenance areas (performance appraisals, disciplinary actions, training / development attendance approvals, etc.
  • and ensures they are skillfully performing assigned work orders and troubleshooting and properly documenting it.

  • Assess and prepare development training in target areas in order to increase technician’s proficiency in current technology and assignments (e.
  • g. FMEA / FMECA documents, RCA (root cause analysis), etc.)

  • Prepares work schedules and match employees with the required skill set for the jobs to be accomplished.
  • Prioritizes the use of resources to most effectively achieve business goals and within budget.
  • Deals effectively with internal and external sources.
  • Handles Hazardous Waste, as required.
  • Knowledge / Skill :

    1. Bachelor in Science Degree in Engineering, Electronics or related field

    2. Five (5) years experience in the operation / maintenance of pharmaceutical manufacturing equipment (e.g. Blenders, Milling Machines, Tablet Press Machine, Aseptic Processing Equipment, Isolators and Lyophilization Process Equipment).

    3. Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.

    4. Ability to provide support during external and internal regulatory audits (FDA, EMEA, Otsuka, Sanofi, etc.)

    5. Ability to troubleshoot problems for highly technical equipment.

    6. Ability to read and interpret complex mechanical, pneumatic and electrical blueprints. In addition, general knowledge in automated equipment functionality and architecture.

    7. Bilingual English / Spanish, both written and verbal and ability to read technical English and equipment manuals

    8. Ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, etc. Computer literate

    9. Excellent interpersonal skills and teamwork oriented, able to work under pressure with subordinates, peers, management and clients.

    10. Self-starter and initiative to undertake / execute activities with minimum supervision.

    11. Ability to review SOPs and work instructions

    12. Flexible and responsible

    13. Significant ability and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data

    14. Self-starter and well organized and have the capacity to interact effectively with people

    15. Ability to keep work pace and / or meet deadlines

    16. Ability to exercise good judgment

    17. Willing to work irregular hours, rotative shifts, weekends and holidays

    Education :

  • Bachelor in Science Degree in Engineering, Electronics or related field
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