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Validation Engineer

2 months ago

Durham, United States Randstad Life Sciences US Full time

5 month contract


Must have:

  • Validation experience on the equipment side, less with computer systems (CSV)
  • Strong mechanical understanding of equipment and electrical diagrams
  • GDP (all writing is done by hand, not computers) and general knowledge of regulatory and compliance

Plus:

  • have worked with liquid handling systems (ex. Hamilton, Beckman, Agilent)



The Validation Engineer 1- Qualification will coordinate, execute tasks, and provide technical engineering support for a variety of assets. They will primarily interact with operations, development scientists, and software engineers to ensure qualified status of our very complex operation.


Expected schedule is Monday to Friday with a first shift start time of 8am. This position may need to support weekends and holidays.


  • Perform and plan qualifications and associated processes to onboard, replace, modify, upgrade, and replace assets to support the area following cGMP/GLP and Quality Management System (QMS) guidelines
  • Execute and document equipment lifecycle-related activities (installations, calibration, qualifications, etc) by supporting and maintaining equipment records in our asset management and quality management systems for traceability purposes and to assure compliance with CLIA/CAP, FDA 21 CFR part 820, ISO 15189, ISO 13485, and other requirements
  • Create, update, and review procedures, work instructions, guidelines, and testing documents such as installation / operational / performance qualification (IOPQ), verifications, standard operating procedures (SOP)
  • Work closely with Quality and regulatory to implement and follow the required policies and procedures for asset qualification, calibration, maintenance, and software validation
  • Participate of the coordination of resources to support qualifications, installations, calibrations, investigations, upgrades, and/or repairs as needed
  • Support root cause investigations
  • Support the creation of new training
  • Support process optimization to improve efficiency and robustness
  • Work together with development and software for successful technology transfer and further workflow improvements
  • Support engineering operations group needs
  • Participate and adhere to Company’s policies and guidelines


Qualifications:

  • 1 - 3+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience
  • Good verbal and written communication skills
  • Good time management skills to support a fast paced working environment
  • Good troubleshooting and root cause analysis skills in both hardware and software
  • Strong experience with writing and implementing test protocols and procedures
  • Strong industrial electrical and mechanical knowledge
  • Knowledge of IT networking and systems infrastructure
  • Knowledge Safety Training, lock out tag out (LOTO), Hazardous material, and waste handling
  • Hands-on experience qualifying equipment in a high throughput operation

Preferred:

  • Experience executing within a computerized maintenance/calibration management system
  • Experience working in a clinical laboratory-regulated environment
  • Experience qualifying liquid handling equipment. (e.g., Agilent, Hamilton, Beckman, Illumina, Dynamic Devices, etc.)
  • Experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems(MES), scheduling software, Customer Relationship Management (CRM) software
  • Experience working with Green Button Go (GBG)
  • Experience working with Illumina NGS technology platforms