16 days old
2017-11-292017-12-29

Tecnico de Servicios Tecnicos Parenterales (Temporal 10 Meses) con Turnos

Pfizer
Temecula, CA 92592
**DESCRIPCIN DEL PUESTO:**







Provides technology and manufacturing science support to the aseptic manufacturing area for lyophilized products.







The role focuses on delivering process and cleaning validation and qualification studies for aseptic process. This involves issuing protocols, executing or coordinating the execution of trials and writing reports.







Other important aspects of the position are continuous improvement of current operations to improve yields, quality and/or productivity using current OpEx methodologies including the design and execution of protocolized development studies required to achieve those gains.







Troubleshooting of manufacturing operations, collaborating to resolve process and technical issues.







Perform product and process impact assessments derived from change controls or investigations







**RESPONSABILIDADES DEL PUESTO:**







+ Author protocols for process and cleaning validation, execute the validation studies in partnership with Operations Departments and write validation reports



+ Implement Continuous Improvements in the different operational areas: author development protocols, execute or coordinate execution of technical experimental studies and write technical reports



+ Ensures that projects and commitments are completed on schedule.



+ Supports troubleshooting and resolution of process deviations. Performs root-cause analysis and identifies appropriate, effective corrective and preventive actions.



+ Process and Product Impact Assessments (for deviations, quality risk analysis and change control)



+ Manage major changes to manufacturing process through site Change Control system







+ Use data from Process Monitoring, Statistical Process Control and Process Capability to support robust decision-making and Continued Process Verification plans.



+ Ability to gather, analyze, interpret, relate and compare information from multiple sources and identify cause and effect relationships



+ Support Compliance Inspections and enquiries from regulatory agencies







+ Participate in cross-functional project teams as applicable to enable equipment design, installation and qualification, technology transfer and New Product Introductions.



+ Evaluate new materials and primary packaging components







+ "On-the floor" technical support to Operations.



+ Develop and maintain productive links with Operations, Quality and Engineering & Maintenance experts across the site to maintain up to date technology skills and knowledge base.







**RELACIONES ORGANIZACIONALES:**







The incumbent will report nominally to the Parenterals Technical Services Manager







The incumbent will work in partnership with Parenterals Manager and technicians as well as Engineering and Quality functions within site and also with external stakeholders (e.g., Global Technology Services...).







**FORMACIN Y EXPERIENCIA:**



Bachelor Degree (or above) in Pharmacy, Chemistry, Engineering or other Life Sciences degree.



At least five years of experience in the pharmaceutical industry in the areas of aseptic product/process development, validation or manufacturing. GMP knowledge is essential for this position.



Green Belt Certification is valuable.



Good English communication skills (oral and written) are required.







**REQUERIMIENTOS DE HABILIDADES TCNICAS**







+ Experience of demonstrating strong customer focus, with ability to support day-to-day work when needed while remaining focused on implementing continuous process improvement changes to meet long-term goals.



+ Sound understanding of statistical experimental design and analysis.



+ Demonstrated success track record in working collaboratively in complex matrix environments is essential



+ Green Belt Certification is valuable







Excellent Spanish and English communication skills (oral and written) are required







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Categories

  • Engineering
  • Manufacturing / Production
  • Healthcare

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Tecnico de Servicios Tecnicos Parenterales (Temporal 10 Meses) con Turnos

Pfizer
Temecula, CA 92592

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Tecnico de Servicios Tecnicos Parenterales (Temporal 10 Meses) con Turnos

Pfizer
Temecula, CA
US

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