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Senior Facilities Validation Engineer

Company: TEKNOVA
Location: Hollister
Posted on: May 8, 2022

Job Description:

Description:OVERVIEWThe Senior Facilities Validation Engineer will provide technical expertise and leadership related to all aspects of facility and utility validation at our Hollister site. This includes project leadership, requirements development, validation plans, change control, protocols, reports, and related lifecycle documentation. This person has expertise in Facilities, Utilities and Equipment providing them or associated with them, this includes environmental monitoring, HVAC, RO/DI, process gas, electrical controls and other utility systems required for support of a regulated manufacturing environment.DUTIES AND RESPONSIBILITIES

  • Leads all aspects of commissioning and validation efforts concentrating on facility and utility systems.
  • Assists and lends expertise in equipment validation, cleaning validation, process validation and computer validation.
  • Leads the development of Validation Plans, URSs, and Qualification Documentation.
  • Participates in activities related to validation including design, build, maintenance, and change control.
  • Partners with others for creation of engineering specifications and designs for utilities and cleanrooms.
  • Leads and participates in risk assessments of new and existing equipment and facilities.
  • Tracks and communicates project status, as well as project risks and recommendations to stakeholders.
  • Responsible for maintaining facility and utilities in a valid state.
  • May perform budgeting and cost-benefit analysis for small/medium capital projects related to infrastructure improvements or upgrades to individual equipment
  • Collaborates with other team members to ensure goals and objectives are achieved
  • Mentor junior engineers; manages vendors; and supervises contractors as required.. Requirements:EDUCATION
    • Bachelor of Science degree in Engineering or Science discipline (Engineering preferred)
    • Advanced degree may be used in place of work experience.KNOWLEDGE / SKILLS / EXPERIENCE
      • Eight (8) or more years of experience in validation, manufacturing, or engineering. At least four years in the biotechnology or pharmaceutical industry.
      • Experience creating master validation plans, protocols, and reports.
      • Experience in clean rooms, RO/DI, pure steam, HVAC and other systems used to support a regulated manufacturing environment.
      • Thorough understanding of lifecycle documentation, include specification development, risk assessments, trace matrix development, protocol development, protocol execution and report writing.
      • Ability to balance scope, schedule, and resources across multiple projects based on business needs.
      • Experience working cross-functionally to develop technical requirements.
      • Experience developing and defending rationale for protocol design, sampling requirements and acceptance criteria.
      • Experience with applicable guidance including: ISO 13485 and 9001; as well as 21 CFR Parts 11, 210, 211, and 820; and ICH Q7.
      • Understanding all elements of a mature Quality System
      • Experience commissioning or validating a new facility
      • Six-sigma green belt or other formal training in statistical methodsEEOC Employer

Keywords: TEKNOVA, Salinas , Senior Facilities Validation Engineer, Engineering , Hollister, California

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