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Senior Quality Engineer (Validation)

Company: TEKNOVA
Location: Hollister
Posted on: November 26, 2022

Job Description:

Description:OVERVIEWThe Senior Quality Engineer (Validation) will apply knowledge of test method development and quality engineering for validation of equipment, processes, evaluate risk, and serve as the subject matter expert (SME) on all validation activities.The role is essentially a frontline role to assure that the Teknova site validation activities comply with applicable customer requirements, external standards (e.g., ISO13485:2016), and regulatory requirements (e.g., 21CFR Part 820, Current Good Manufacturing Practices, Good Distribution Practices where applicable), and expectations for the development and reliable supply of quality products. The position supports the site validation, qualification process as well as change controls associated with facility, equipment, processes, and systems. The individual will: (a) provide quality, compliance, and technical oversight, (b) will approve all associated documents for Quality Engineering (c) will create and update associated procedures to ensure compliance with internal and external requirements.Additional responsibilities include quality engineering document reviews as well as interacting with stakeholders and customers as needed to resolve issues and concerns related to impact of changes to equipment, facilities, utilities, new equipment, systems, and processes.DUTIES AND RESPONSIBILITIES

  • Identify quality characteristics and validation criteria for test methods used for equipment and process qualification and ensure test method development and validation activities are conducted in accordance with applicable internal and external requirements.
  • Ensure all necessary quality documents, protocols, reports, and procedures are completed and assessed for impact to processes and customer requirements.
  • Review, comment and approve protocols and reports.
  • Track, monitor, and manage all associated project plans and relevant document to support changes. Manage stakeholder expectations in accordance with applicable standards and regulations.
  • Ensure all work is performed and documented accurately, timely and in compliance with internal procedures.
  • Design and develop test strategies for validation products.
  • Interact with all levels of the organization and support the generation of project plans, metrics, and KPI (Key Performance Index) as applicable to the scope of responsibilities within the position.
  • Troubleshoot issues of concern with internal team(s) to provide the highest quality solutions which meet the needs of the organization.
  • Participate in audits as a representative of Quality Engineering for internal, external, as well as regulatory inspections.
  • Drive special projects or assignments for Quality Engineering.
  • Incorporate quality risk analysis where required.
  • Promote a quality mindset and quality excellence approach to all activities.
  • Train Quality Associates on processes to ensure records/reports are complete, accurate, and submitted by agreed timelines.
  • Mentor less senior quality engineers on quality engineering techniques and test method validation.
  • Identify and support continuous improvement opportunities working cross-functionally to enhance quality engineering functions.
  • Encourage a safety mindset and focus on safety for all quality activities.
  • Other duties as required.
    STANDARD PERFORMANCE EXPECTATIONS
    • Strong content knowledge of ISO 13485:2016, cGMP, and regulatory compliance.
    • Quality Engineering and Manufacturing Engineering techniques experience preferred.
    • Embrace the principles and ethics described in the Teknova Mission Statement and Core ValuesRequirements:EDUCATION
      • Bachelor's Degree BS/ BA (or advanced degree) in Chemical Engineering, Biology, Biochemistry, Chemistry, or another science-related field.
      • Minimum of 5 years of related work experience; 5+ years of Quality experience within In Vitro Diagnostics, Pharmaceutical, or other similar regulated industry.KNOWLEDGE / SKILLS / EXPERIENCE
        • Solid knowledge of quality systems procedures, cGMP, and documentation
        • Must be well organized and detail-oriented
        • Must be able to move about the facility
        • May be required to wear personal protective equipment
        • Strong computer experience
        • Knowledgeable using Excel, Word, Power-point
        • Statistical analysis with Excel, Minitab, JMP
        • Excellent communication (written and verbal) and interpersonal skills
        • Facilities and Cleanroom manufacturing experience is a plus along with a comfort level with full ISO 5 and ISO 7 gowning requirements

Keywords: TEKNOVA, Salinas , Senior Quality Engineer (Validation), Engineering , Hollister, California

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