Job Description :
Test Method Validation Engineer
Location: Plymouth MN
Experience Required: 7+ Year
Must have skills*
The Validation Engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility.
He should have following technical and functional skills:
? ? ? ? Understand testing and inspection procedures
? ? ? ? Skill to develop test method validation standard operating procedures
? ? ? ? Understand measurement system analysis techniques
? ? ? ? Able to write validation protocols
? ? ? ? Understand and develop sampling plan
? ? ? ? Able to execute test runs, analyze data and generate report.
? ? ? ? Knowledge of statistical tools for data analysis
? ? ? ? Able to train test operators or other staff on test procedure, method validation protocols, sample preparation, good documentation practice and standard operating procedures.
? ? ? ? Ensure compliance with internal or regulatory requirements.
? ? ? ? Additionally, able to develop validation master plans, process flow diagrams, test cases, or standard operating procedures for process, equipment, software and product validation.
? ? ? ? Able to conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
? ? ? ? Able to conduct meetings with stake holders or approvers
? ? ? ? Understand all customer/company and GMP procedures, along with safety regulations within the workplace.
Experience Required
? ? ? ? A minimum of 4 years’ experience in a highly regulated industry is required. Medical Device and/or Pharmaceutical industry is preferred.
? ? ? ? Experience in interpreting engineering documents like product specification (PDS), risk documents (FMEAs), testing and inspection process, Statistical graphs or charts, engineering diagrams, blueprints, equipment manuals/guides and other instructions to solve problems.
? ? ? ? Experience in identifying complex problems and developing and evaluating options and implementation of solutions.
? ? ? ? Additional experience in Process and Product Validation is added advantage
? ? ? ? Also experience in writing User requirements (URS), Functional Requirements (FRS), Design Specifications (DS), Factoryl Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) documents.
? ? ? ? Experience executing FAT’s, SAT’s, receipt verification, IQ, OQ, PQ.
? ? ? ? Excellent problem solving and decision-making skills will be required. Interpersonal skills that foster conflict resolution as it relates to technical situations will be required.
? ? ? ? Also Process validation experience is required.