Pfizer Packaging Technical Services Technician in Madrid, Spain
DESCRIPCIÓN DEL PUESTO:
The role focuses on delivering process and qualification studies for packaging process and cold chain shipments. This involves issuing risk assessments, protocols, executing or coordinating the execution of trials and writing reports.
One important aspect of this position is to design new materials templates and/or specifications. Evaluate new markets and/or changes in the formats in the packaging line, including serialization requirements. Evaluate and develop a new process format maintenance process and create new formats in the packaging line equipment.
Other important aspects of the position are continuous improvement of current operations to improve OEE, quality and/or productivity using current OpEx methodologies including the design and execution of protocolized development studies required to achieve those gains.
Troubleshooting of packaging and shipping operations, collaborating to resolve process and technical issues.
Perform product and process impact assessments derived from change controls or investigations, including changes in packaging materials and Medical Devices.
RESPONSABILIDADES DEL PUESTO:
Author protocols for process and shipping 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.
Ability to gather, analyse, 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, packaging components (secondary and tertiary) and shipping containers.
Manage the changes of Medical Devices and packaging materials and evaluate their impact in the Design History File for Combination Products.
"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.
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.
Knowledge of packaging equipment and process.
Expertise in serialization process for packaging lines and warehouse.
Knowledge in Combination Products and Medical Devices regulations
The incumbent will report nominally to the Packaging Technical Services Manager
The incumbent will work in partnership with Packaging and Warehouse Managers and technicians as well as Engineering, Supply Chain and Quality functions within site and also with external stakeholders (e.g., Global Technology and Engineering...).
FORMACIÓN Y EXPERIENCIA:
Bachelor Degree (or above) in Pharmacy, Chemistry, Engineering or other Life Sciences degree.
At least two years of experience in the pharmaceutical industry in the areas of packaging product/process development, validation or manufacturing.
GMP knowledge is essential for this position.
Good English communication skills (oral and written) are required.
REQUERIMIENTOS DE HABILIDADES TÉCNICAS
Demonstrated success track record in working collaboratively in complex matrix environments is essential
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.