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Serialization Validation Engineer

Company: Automated Systems, Inc.
Location: Woodstock
Posted on: January 13, 2022

Job Description:

Job Overview: Automated Systems, Inc. is currently looking for a mid to senior level serialization validation engineers to work on-site at Woodstock, IL. Candidates must have hands on validation experience on Number Range Management System, serialization packaging equipment and related interfaces and business to business data transfer validation. Candidates must have proven knowledge of validation design and qualification life cycle of the end to end serialization process verification. Prior experience working with automated vial labelers, cartoners, shipper/case packing equipment, and automated serialization packaging equipment is preferred. Must have proven knowledge and experience working in FDA regulated environment, and proven skills on supporting design, engineering, commissioning and qualification projects including cloud based Number Range Management System Validation. Requirements Required Skills: Effective communication and interpersonal skills in interfacing with equipment vendors and cross functional organization teams to review and update the URS, Design Specs and Functional Specs and Qualification documents in order to support the project needs. Proven years of experience in computer system validation in regards to serialization process setup, installations and validation. Review specification documents, creating and execution of CSV documents for serialization NRM system and packaging equipment in support with cross functional team to ensure compliance to cGMP and GDP. Review specification and validation documents issued by the system and/or equipment suppliers to ensure the completeness and technical accuracy. Active participation in validation and release of the packaging equipment during and after validation completion. Develop a strong working relationship with the internal and external stakeholder of the project and work respectively within a collaborative team environment. Proven excellence in authoring and execution of the CSV documents (IQ,CQ, OQ, PQ) by means of excellent MS Office Suite skills (MS Word, Excel etc.). Detail oriented, self-motivated and a team player. Ability to perform analysis of the situation and provide recommendations to meet the needs of the project in highly paced pharmaceutical manufacturing environment. Problem solving, creative thinking and interacting with upper management and equipment workers/engineers. Ability to work independently and lead the project and organization goals to deliver the results in given timeline. Degree and Experience: B.S. in Science or Engineering (life science, pharmaceutical engineering, computer science is preferred). Minimum 4+ years of experience is preferred in regulated pharmaceutical, life science or medical device industry. Job Requirements:

  • Integrate test equipment and test software to support software validation/verification
  • Implement software product validation tests
  • Beginning computerized system validation activities
  • Assist with defining validation strategy
  • Communicate validation roadblocks or challenges
  • Maintain business wide validation practices
  • Create and maintain validation test plan and specific validation features required for each product
  • Evaluate computer system validation and system development lifecycle (CSV & SDLC)
  • Perform validation assessments of new and existing software to determine the level of validation
  • Oversee user testing and ensure validation testing is conducted
  • Provided validation packages and develop validation strategy by aligning with the clients standards
  • Assure proper understanding of validation activities
  • Setting and maintaining computerized system validation standards via computerized system validation SOPs
  • Develop test methodologies for validation/verification of system and subsystem software performance
  • Set and meet lead times for validation testing
  • Develop validation designs including alternatives to manual testing
  • Develop validation methods and procedures including automated testing
  • Analyze and act upon metrics from validation testing
  • Develop a validation strategy and project plan
  • Generate and maintain cleaning validation master plans

Keywords: Automated Systems, Inc., Elgin , Serialization Validation Engineer, Engineering , Woodstock, Illinois

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