Process Validation Engineer

Confidential Company  •  San Jose, CA

11 - 15 years experience  •  IT Consulting/Services

Salary depends on experience
Posted on 08/15/17 by Cynet EngineeringTeam
San Jose, CA
11 - 15 years experience
IT Consulting/Services
Salary depends on experience
Posted on 08/15/17 by Cynet EngineeringTeam

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

Job Description:

  • 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

Mandatory Skills:

  • 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.

Desired Skills:

  • Medical Quality Management system
  • Medical device Regulatory exposure
  • Experience in Automated manufacturing Line
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