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.
MAJOR DUTIES AND RESPONSIBILITIES
* Owns the CMMS program. Along with the site CMMS administrator, manages and troubleshoots the CMMS. Identifies opportunities to upgrade or replace hardware/software to meet the current and future needs of its users and management, recommends changes, and participates in the acquisition, implementation and follow-on management of purchases.
* Ensures system, software, training, and reports accurately and effectively function with the most current versions and applications. Participates in requisite CMMS training and education and keeps abreast of software changes in order to remain informed on its use and function.
* Design and implement the program for the CMMS administrator to coordinates the planning, design and establishment of data entry standards used in the CMMS. Establishes, reassigns, revises or deletes records in key data tables in response to system user requirements as applied through use of department policies and standards.
* Ensures the design of the CMMS software security levels for individuals and groups are in accordance with the guidelines and objectives provided by IT and Part 11 compliant.
* Develops and manages standards/procedures used for entering facility-wide information, and setting system defaults for each site, purchasing center, and warehouse.
* Coordinates with Engineering, Information Technology (IT), and CMMS users to facilitate the importing and exporting of equipment, inventory and other data.
* Designs and creates reports and other reporting tools used in work order and inventory analysis graphs.
* Monitors the change process for system procedures and standards. Evaluates change proposals, coordinates change development, and implements change. Develops tests and evaluates application responses to changes in operating, application, and data environments.
* Manages the establishment and use of global codes used in the CMMS.
* Coordinates with the Departments Shops in the management of facility asset records and preventative maintenance schedules. Performs periodic analysis of preventative maintenance program and presents analysis to Department Managers/Supervisors.
* Advises on and participates in the training of the CMMS users.
* Ensures back-up to the Work Order Gatekeeper Desk and CMMS administrator is available at all times.
* Ensures there is a sustainable interface between maintenance, purchasing, and inventory to support the maintenance function including the establishment and maintenance of equipment master, labor, and inventory records.
* Owns the Planning and Scheduling process and procedures, responsible for the plan/schedule attainment of the Production Maintenance, Calibrations the Calibration of Critical Utilities.
* Ensures a plan and schedule work, processes, and materials, primarily managed through the use of a computerized maintenance management system (CMMS)
* Ensure with the team of CMMS and Planners/Schedulers the effective execution of all maintenance work control processes.
* Ensure a safe, effective, and efficient work control plan through proper planning and scheduling of work for various crafts including Operations and Maintenance Technicians, Industrial Maintenance Mechanics, Electricians, Instrumentation and Control Specialists, Building Maintenance Workers, Building Equipment Operators and other classifications is developed.
* Monitor the technical performance of the CMMS make any necessary adjustments to ensure that best-in-class standardized usage practices are followed. Performance is evaluated through observation, conferences, reports, and/or results obtained.
* Ensures work is prioritized through a defined categorization of process/asset criticality and equipment redundancy; Establish a system to ensure work requests/orders are accurate and clear, the validity and accuracy of information and that the appropriate resources to set a preliminary priority are engaged
* Ensures planners/schedulers obtains and organizes all information required for the work being performed. (i.e. drawings, vendor manuals, supplemental materials, special procedures, diagrams, permitting, etc.); scheduled work orders with labor availability and skills is balanced;
* Measures and monitors backlog for adherence to site and SOP standards;
* Ensures planners/schedulers develop, maintains and monitors a weekly schedule for all crafts in accordance to local procedures and the highest reliability centered maintenance strategies
* Support internal and external regulatory audits;
* Performs other duties as assigned
DECISION MAKING
* It is expected that he/she to take key and timely decisions that will have a direct impact in the Operation and BMS. Decisions will require taking immediate actions, prioritizing, negotiation, independent judgment, resources allocation and development of future corrective actions to avoid recurrent of events. Delayed decisions may cause: A potential loss of the batch and a significant amount of money and/or time, Additional manufacturing time, increased product cost, Planning and Customer commitment delays, loss of confidence and reputation and risk of1integrity of the product, among others.
* High degree of dedication and commitment to support the laboratory, manufacturing and maintenance goals.
* The effective performance of this position will be reflected in the manufacturing and maintenance outcome and it will have a direct impact in the effectively use of resources, minimizing equipment downtime and their availability to manufacture, and overall quality of manufactured products.
* Requires anticipating problems and coordinating solutions.
* In process review of performance with manager along with a regular review of major assignments for completion and accuracy.
* The incumbent is expected to provide service to a group of three shifts and 24/7 shifts coverage for the Laboratory and Production Area including weekends support of manufacturing activities
* The incumbent must be able to work with multifunctional groups and also to work independently to accomplish those goals/objectives agreed with the Management.
* The objectives and tasks accomplishments shall be based in current GMPs, existing operational procedures and BMS policies and internal controls.
* Notify immediate supervisor of any inconsistencies or violations to Company operation procedures and policies
CONTACTS
* Daily communication with area supervisors and/or managers.
* Daily and close communication with the planner, schedulers and CMMS Administrator, Stores Manager.
* Daily communication with his supervisor and other team members.
* Occasional contact with external suppliers or contractors.
KNOWLEDGE/SKILL
* BS in Computer Science, Engineering, Electronics or related technical field.
* Five (5) years experience in a supervisory role in a manufacturing environment for maintenance or calibrations or equivalent role
* Three (3) years experience in CMMS administration of equivalent Database/Maintenance Management use or administration
* At least two (2) years of experience in the planning and scheduling or a combines experience for maintenance and calibrations (in the role of a planner, supervisor or as the supervisor of planners and schedulers)
* Knowledge of cGMPs, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant.
* Timely and effective decision making, and timely conflicts resolution skills.
* Ability to organize and prioritize workload and meet deadlines in a highly technical and rapidly changing environment.
* Ability to troubleshoot problems for highly technical equipment.
* Computer literate with the ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, MAXIMO, etc.
* Ability to read and interpret layout drawings, mechanical, pneumatic and electrical blueprints, is preferred
* General knowledge in automated equipment functionality and architecture.
* Fluently in English/Spanish (Oral and Written)
* Strong interpersonal relationship skills with subordinates, peers, management and clients.
* In-depth knowledge in the design, installation, commissioning and validation/qualification of equipment/instruments as applied to pharmaceutical production environment.
* Experience with external and internal regulatory audits (FDA, EMEA, etc.)
* Good technical writing skills and ability to review SOPs and work instructions
* Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data
* Excellent oral and written communication skills in both English and Spanish.
* Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
* Self-starter and able to plan and prioritize multiple complex activities simultaneously (i.e.: installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project
* Proven management Skills.
* Willing to work irregular hours, rotating shifts, and any day of the week
* Able to work within constraint time frames expeditiously.
WORKING CONDITIONS
* Occasional exposure to disagreeable conditions.
* Occasional exposure to potentially hazardous conditions.
* No significant travel required in and out Puerto Rico mostly for training.
* Average absences from home of one or two nights per month not due to shift work.
* Minimum personal protective equipment (safety shoes, safety glasses, hard hat) required.
* Frequent writing and use of keyboard.
* Special gowning as defined and required in the Manufacturing/Laboratory and required areas.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Summit, NJ
Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies for the treatment of cancer and inflammatory diseases worldwide. It offers REVLIMID, an oral immunomodulatory drug for multiple myeloma (MM), myelodysplastic syndromes (MDS), and mantle cell lymphoma; POMALYST/IMNOVID to treat multiple myeloma; OTEZLA, a small-molecule inhibitor of phosphodiesterase 4 for psoriatic arthritis and psoriasis; and ABRAXANE to treat breast, non-small cell lung, pancreatic, and gastric cancers.
The company’s products also include IDHIFA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (rrAML) with an isocitrate dehydrogenase-2 mutation; VIDAZA, a pyrimidine nucleoside analog for intermediate-2 and high-risk MDS, chronic myelomonocytic leukemia, and AML; THALOMID to treat patients with MM; and ISTODAX, an epigenetic modifier. Its preclinical and clinical-stage product candidates include small molecules, biologics, and cell therapies for immune-inflammatory diseases, myeloid diseases, epigenetics, protein homeostasis, and immuno-oncology.
The company has agreements with BeiGene, Ltd; Acceleron Pharma, Inc.; Agios Pharmaceuticals, Inc.; bluebird bio, Inc.; Lycera Corp.; Juno Therapeutics, Inc.; EXSCIENTIA LTD.; and IMIDomics SL, as well as immuno-oncology collaboration with Sutro Biopharma. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.