- Manatí, Puerto Rico
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.
Accountable for the instrumentation/calibrations and metrology services and activities in the site, personnel and assigned budget. This in compliance with applicable regulatory requirements and the site's internal procedures. Provide the leadership to BMS Manatí Metrology program that comprehends planned and unplanned calibrations. Establish the adequate processes, procedures, tools and training to the calibration organization that performs troubleshooting, instrument configuration activities, support regulatory audits, periodic review of instrument performance, calibration, coordination of activities with impacted areas and external suppliers, schedule preventive and corrective calibrations and provide daily support to the instrumentation clients through the site. Must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
- Accountable of the Instrumentation/Calibrations group to assure that required process, laboratories, utilities and facilities equipment calibrations are performed in compliance with NIST, cGMP regulations, company policies and procedures and meet Federal and local governmental regulation (e.g. FDA, EQB, OSHA, etc.).
- Manages departmental budget to ensure area consumables, external services, personnel training, tools and facilities are provided to personnel and areas serviced. Manage projections of expense and controls based in site needs and priorities.
- Responsible of the efficient personnel organization to comply with calibration schedules in alignment with site manufacturing schedule. Provides solution-solving techniques and/or troubleshoots routine and unusual problems.
- Ensures that proper spare parts inventory is available in the stock room and personnel has the necessary skills to complete their tasks (e.g. instrument configuration)
- Manages resources effectively and efficiently within budgetary constraints and evaluates personnel capabilities to provide adequate training.
- Encourage team to create, identify and implement new and innovative ideas/technologies for the successful development of business opportunities within and outside of the Instrumentation/calibrations area.
- Participate in operational and strategic planning, regulatory and performance meetings.
- Ensures communication forums are available for all employees.
- Develops new systems, practices and procedures to enhance the performance of the business.
- Facilitates change through creative administrative and technical solutions that are grounded in a realistic assessment of what can be achieved.
- Develops required equipment spare parts list to assure minimum equipment repair time.
- Establish Key Performance Indicators (such as overtime used, Cal Schedule compliance, failure trend, schedule compliance) and provide/execute corrective actions plans based on performance.
- Perform/Evaluate Change Control, Quality Events and CAPA/Stand Alone action related documentation and instrument performance and ensures its adequacy and on time completion.
- Troubleshoots routine and unusual technical / administrative problems.
- Participates in regulatory audits as SME and assure areas of responsibility readiness in preparation for PAI and other Regulatory Agencies audits.
- Performs performance appraisals to all personnel under his/her responsibilities following BMS policies and procedures
- Executes employees' performance improvement plans, development and disciplinary actions as required.
- Keeps abreast of reliability principles applicable to site instrumentation and calibration workflow.
- Ensure all work areas are safe and organized based in a 5S program these should be prepared to increase the employee performance.
- Assures reported problems are solved by implementing corrective actions like (but not limited) user retraining, changes to existing SOPs, applying software fixes or hardware fixes, Information Resources colleagues recommendations, etc. These activities must comply with current applicable change control procedures.
- Provides sound problem solving techniques to resolve issues and calibration problems.
- Assist in the definition and need of Capital Appropriation Requests (CAR's), their timeline implementation.
- Prepares weekly reports (e.g., highlights on area performance, budget, etc.).
- Approves the purchases for the parts and services required in the calibrations areas in accordance to budget.
- Prioritizes the use of resources to most effectively achieve business goals and within budget.
- Deals effectively with internal and external sources.
- Review and approval of maintenance records.
- Ensure reliability strategy is followed to proactively ensure the highest availability of the instruments and standards.
- Ensures departmental work completion, quality and timeliness.
• BS in Electrical, computer, Mechanical Engineering, Electronics and or related fields.
• Eight (8) years' experience in instrumentation technology for processing, laboratories, utilities and facilities equipment in a pharmaceutical manufacturing environment.
• Five (5) years experience in a supervisory role in a pharmaceutical environment.
• Knowledge of cGMP's, 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 complex mechanical, pneumatic and electrical blueprints.
• 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/insturments as applied to pharmaceutical production environment.
• Experience with external and internal regulatory audits (FDA, EMEA, etc.)
• Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
• Able to read, interpret, and understand electrical/mechanical drawings and instrument installation requirements.
• 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
• Management Skills.
• Willing to work irregular hours, different shifts, weekends and holidays, when necessary
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.
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