Validation Consultant

PharmEng Technology is currently seeking a Validation Engineer assist our team for projects in Boca Raton, FL USA.
Job Description:
  • Develop and execute documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include: Project Validation Plan, Requirements Trace Matrix, Risk Assessment, IQ/OQ/PQ, Validation Summary Report, Data Transfer and Integrity Testing Protocol, Change control, SOPs, etc.
  • Support development of validation deliverables, such as Functional Requirements Specification (FRS), Detailed Design Specification, etc
  • Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control, etc.
  • Ensure compliance of computerized systems to relevant regulatory requirements (e.g. cGMP/GLP/GAMP/GALP).
  • Complete assigned projects and tasks within agreed deadlines.
  • Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects
  • Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports
  • Prepare validation documentation packages and complete validation of Computerized Laboratory Systems
  • Acts as liaison between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guidelines.
  • Assist in the development of a validation remediation strategy, as required
  • Improve data quality of the system, harmonizing when necessary through the development and implementation of change controls (patches), or implementing a process to improve the quality of the information.
  • Ensure accuracy and timeliness of manual migration data updates
Job Requirements:
  • Ideal candidate would have worked in GMP Lab environment and done CSV for lab instruments
  • Scientific background (Chemistry, Biology),  or IT background (with specialty / experience in Lab systems)
  • Agilent systems (HPLCs, LCMS, GCs)
  • Waters systems (HPLC, LCMS)
  • Plate Readers (Softmax Pro), Plate washers, 
  • Spectrophotometers (Beckman, Agilent)
  • DNA Sequencers (Sciex, Roche)
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
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