Neomed Labs Pacific Biomarkers PAIRimmune are now Nexelis
 

Validation Specialist (Seattle)

Location

Seattle

Work schedule

Permanent, full time

Start date

As soon as possible

Should you consider yourself to be among the best Validation professionals in town, here is your chance to participate in the daily life of the most successful advanced testing service provider in the immunology field. Involved in more than 15 SARS-CoV2 vaccine developments in partnership with multinational pharmaceutical companies, innovative biotechnology companies and prestigious NGOs such as Bill and Melinda Gates Foundation or CEPI, we also proudly serve the needs of our clients in fields such as flu (universal and seasonal), meningitis, respiratory syncytial virus, chikungunya, malaria, or HPV and are growing an immune-oncology franchise.

 

Benefits

  • Medical, Dental, Vision Insurance
  • Travel Assistance
  • Employee Assistance Program
  • 401k and Employer Matching
  • 11 Paid Holidays
  • Generous Vacation and Sick Time
  • Healthcare Reimbursement
  • Great location in Seattle (Interbay / Lower QA)

Position Responsibilities

  • Write validation deliverables (VP, URS, FS, RA, DS, UTCR, IQ/OQ/PQ, TM, VR, etc.) and ensure qualification execution according to business priorities and internal procedures;
  • Coordinate multiple validation projects and coordinate their timely delivery with key stakeholders and external collaborators (team members, validation consultants, QA, IT, scientists, vendors);
  • Ensure laboratory equipment and software life cycle management is carried out according to business strategy and internal procedures;
  • Maintain regulated system access & train laboratory personnel in their operation with established procedures. Provide ad-hoc expert support on certain computerized systems;
  • Diagnose hardware/software issues & devise solutions in close collaboration with scientific personnel and vendors;
  • Coordinate the facility & laboratory equipment maintenance program (calibration, preventive maintenance, repairs), ensure the timely review of all service reports and the proper remediation of any discrepancies with internal procedures and external vendors;
  • Administrate the facility environmental monitoring system.

Experience and Qualifications

  • Excellent analytical and problem-solving skills;
  • Ability to work methodically with a concern for precision and accuracy;
  • High focus required in order to execute complex interventions autonomously;
  • Excellent individual and team-work, service oriented and organizational skills;
  • Proficient with office tools (Outlook, Excel, Word, Power point);
  • Minimum 2 years experience working in a regulated pharmaceutical environment;
  • Minimum 1-2 years experience at validating laboratory equipment for regulated use.

Education

Bachelor’s degree in engineering

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  • This field is for validation purposes and should be left unchanged.
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