מדעים/ביוטק

CONFIGURATION AND VALIDATION ENGINEER

693599

תאריך עדכון

25/11/2021

תיאור המשרה

As a Configuration & Validation Engineer you will be responsible for configuration management of company's products, validating/qualifying the processes, systems, equipment, facilities, and /or utilities used to manufacture company's products.

Essential Job Functions:

· Manages, schedules and executes sterilization validations, equipment and other required testing/qualifications in production line per company's procedures, protocols and regulatory guidelines. Prepare all required protocols and reports.

· Prepare process validation protocols, reports and plans in order to launch new products and/or upgrade existing manufacturing processes.

· Executes Change Control process, lead CCB meetings, follow ECO tasks, compiles ECO documentation.

· Maintains products configuration, production specifications and documentation including packaging and labeling.

· Coordinates and communicates validation/ECO activities with affected functional groups and evaluates the results.

· Evaluate and score risks associated with manufacturing processes and prepare detailed reports identifying chance of failures and risk-control measures in place. Identify areas of concern and possible improvement opportunities

· Gather, track and statistically analyze process data when necessary

· Perform investigations to determine the root cause for manufacturing process failures, initiate problem resolution and participate CAPA meetings.

· Participate and present data in Regulatory Agency, Customer and Internal audits.

· Participate in development/improvements to the validation program as needed to remain current with cGMPs and industry standards.

Education, Experience and Skills:

· Bachelor’s degree in Chemical, BioMechanical Engineering or Science Related Field

· 3-5 years of validation experience supporting pharmaceutical/medical device cGMP manufacturing in clean rooms environment

· Product configuration knowledge and experience in ECO process

· Experience authoring, executing and summarizing validation qualification protocols and reports

· Technical writing and excellent attention to detail and working knowledge of FDA Regulations/Guidance and / or Good Manufacturing Practices is required

· Regulatory inspection experience with external regulatory authorities

· Excellent verbal and written communication and ability to work both independently and in partnership with others

· Knowledge and experience with process, equipment, facility, utility or computer system validation, as related to sterile products and medical devices is preferable

· Time management and ability to handle multiple tasks on time and strong conflict resolution skills 

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