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job location Job Location:

Cambridge, Boston, MA, U.S.A.

 

Computer System Validation Expert

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English
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job at pqe

Due to a constant growth, PQE is looking for a new Senior Validation Specialist.



    Responsibilities:
  • Evaluate qualification and validation projects to establish technically and scientifically sound protocols and test plans.
  • Execute protocols by carrying out the preapproved testing in the operations and laboratory areas.
  • Collect and analyze all data, write final report and obtain approvals.
  • Review technical documentation (batch records, SOPs, calibration records, preventive maintenance, work orders, protocols, reports) for continuity and accuracy.
  • Perform gap assessments and remediation as required on legacy qualification and validation packages.
  • Write SOPs and protocols to support departmental programs and projects.
  • Evaluate, maintain and operate validation instrumentation as required in order to support assigned projects (examples: Kaye Validator 2000, dew point monitor).
  • Coordinate successful execution of projects by working effectively with cross-functional groups.
  • May be involved in investigation and root cause analysis for incidents reported on validated systems
  • Other duties, as assigned
    Qualifications/Requirements:
  • Technical Bachelor’s degree in a scientific discipline, or equivalent experience
  • 5+ years of experience in pharmaceutical industry
  • Ability to work harmoniously and effectively with others in a fast-paced environment.
  • Ability to effectively communicate technical information in a clear, concise manner within a GMP-regulated environment
  • Flexibility to work off-hours and weekends as required to support manufacturing plant projects
  • May be required to move about the facility
  • May be required to remain sedentary for periods of time
Full-Time Job

Our collaborators are engaged, developed, challenged and well-rewarded for performance.
We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.


job at pqe