Process Validation Engineer
11 - 15 years experience • IT Consulting/Services
We are looking for Process Validation Engineer for our client in San Jose, CA
Job Title: Process Validation Engineer
Job Location: San Jose, CA
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
- Perform Process validation for Manufacturing facility/ process equipments/ testing equipments
- Perform GxP / Quality assessment to determine if the system fall under GxP and needs to be validated.
- Author User requirements, Process Validation Plans, Process Validation Protocols (IQOQPQ), Risk Assessments and Validation report along with associated documentation.
- Verifies that validation activities once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
- Designs and develops efficient test strategies, procedures, and/or scripts for verification and validation.
- Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed.
- Work with various functions on Process validation to ensure best practice is followed. Provides assistance when required with the preparation of validation protocols, design specifications and associated documentation for systems
- Provides software validation/compliance/part 11 assistance in accordance with policies and SOPs. Participates in Validation project teams and assists in determining project schedules.
- Ensures that Process validation is carried out in compliance with company policies and SOPs.
- Knowledge in CSV (Computer System Validation) is added advantage
- Minimum 10 years’ experience of working in a validation role within the medical device or healthcare industry.
- Experience in Software and Hardware evaluations & assessments for manufacturing / testing equipments
- Knowledge in standards and regulations for Medical device industry.
- A thorough working knowledge of SDLC, GAMP and 21CFR Part 11.
- Excellent understanding of validation/qualification principles, industry practices, and standards with demonstrated ability to apply these to GxP operations.
- Excellent verbal and written communication skills, including the ability to influence others and lead complex projects.
- Medical Quality Management system
- Medical device Regulatory exposure
- Experience in Automated manufacturing Line