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
