Pfizer Validation Specialist in Catania, Italy
Pfizer is recruiting an expert and enthusiastic Validation Specialist for the manufacturing site in Catania.
The Validation Specialist will be responsible for validating/qualifying the systems, equipment, utilities used to manufacture and/or clean drug products within manufacturing facility located in Catania, Italy. S/he will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products. knowledge of GMP and management of quality through quality systems. Member of Compliance forum and Validation Network. Reports to a Validation Supervisor.
Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines.
Coordinates and communicates all testing with affected functional groups and evaluates test results.
Executes validation activities to include Change Control initiation, protocol preparation, scheduling, protocol execution, data review and final report generation.
Participates and presents data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
Participates in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards.
Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Supports cleaning program through swabbing and visual inspection.
Supports aseptic operations during media fill simulations, autoclave and lyophilizer re-qualifications and area requalifications.
Provides support for additional focus area if needed: Automation, Facility Support.
Assists in ensuring future equipment meet the technical requirements of the operation.
Contributes to the selection and integration of new equipment and services, ensuring validation, quality requirements and the process capability of the equipment is in line with pre defined needs.
Supports and develops equipment/services robustness and manage the risks and impact of failure.
Manages minor projects which include all operational and financial aspects. Drive quality, safety and continuous improvement related activities.
Delivers training and support to ensure efficient use and deployment of equipment.
Bachelor or Masters degree in Engineering, manufacturing technology or closely related field, or combination of education and work experience.
3 years of pharmaceutical industry experience required for consideration.
knowledge of GMP and management of quality through quality systems.
Some knowledge and experience with equipment, facility, utility or computer system validation, as related to sterile products preferred.
Understanding of process parameters, process scale-up, and knowledge management with experience of trouble shooting manufacturing and equipment/facility processes.
Understanding of facility design and associated building management systems.
Suitable understanding of engineering operations including, instruments, controls and mechanical aspects of pharmaceutical manufacturing equipment and associated services.
Planning and organizational skills to project manage the operational and financial aspects of capital projects.
Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working.
Proven ability to deliver technical reports and presentations.
The job requires to operate pieces of manufacturing equipment and may require business trips for FATs as well as business meetings (may require travel).
Standing, walking, bending, climbing, reaching and lifting upward of 25 kilos may be required.
Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required.
The incumbent must be able to work multiple shifts as needed to meet deadlines
Deadline to apply: December 19
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.