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Validation Scientist

Company: Randstad USA
Location: Fort Worth
Posted on: June 24, 2022

Job Description:

Validation ScientistDirect-Hire (Perm Role)Location: Fort Worth, Texas (On-Site)Shift: 1st shift, Mon thru Fri, 8am to 5pm
SUMMARY / OBJECTIVE:A Validations Scientist (VSc.) is responsible for the commissioning, qualification, and validation (CQV) activities at Sovereign Pharmaceuticals. The role requires a basic understanding and work experience with the validation requirements associated with a pharmaceutical manufacturing facility.

  • A VSc. is knowledgeable and experienced for site compliance related functions for validation activities (e.g., Process Validation, IQ OQ PQ Validation, Computer System Validation (CSV), and Method Validation).
  • Coordinates and leads validation project execution for equipment, critical utilities, automated systems, software, cleaning validation, and process validation.
  • Works within the documented Risk Management System for Validations.
  • Authors with guidance and executes validation protocols.
  • Ensures protocols, records, and procedures are compliant with current Good Manufacturing Practices (cGMP), Good Automated Manufacturing Practice (GAMP), and Sovereign's SOPs.
  • Writes specifications (design requirements, functional requirements, and user requirements), trace matrices, validation summary reports, and test protocols for installation, operation, and performance under the guidance of the department management.
  • Writes, and revises SOPs.
  • Good working knowledge of regulations and guidance's (e.g., 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, ICH, ISPE, PDA, MHRA, PICs).
  • Has a good understanding of the concepts of data integrity and statistical treatment of experimental data. Can, with supervision, review and recognize laboratory data that is compliant to applicable regulations and meets study protocol acceptance criteria.
  • Writes Technical Reports that summarize the execution of the protocols which express conclusions that are congruent with the experimental results.
    • Bachelor's Degree in a physical or an applied scientific discipline (e.g., Chemistry, Engineering) with three years of experience is required in areas of validation, qualification, and commissioning in the pharmaceutical industry.
    • Demonstrated experience with authoring and execution of documentation including validation documentation, technical protocols, and technical reports.
    • Demonstrated ability for supervised work that requires multi-tasking and a high level of attention to detail.
    • Demonstrated ability to be an active participant on teams.
    • A working knowledge of project management skills and techniques to ensure one's own projects are executed on time.
    • Knowledge of FDA Current Good Manufacturing Practices (cGMP) and Good Automated Manufacturing Practices (GAMP) requirements.
    • Demonstrated experience with responses for FDA, EMA, or other regulatory agencies requests.
    • Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint).
      • Bachelor of Science Degree in Chemistry with three years of experience in areas of validation, qualification, and commissioning in the pharmaceutical industry.
      • Demonstrated experience with the execution of Design of Experiments protocols to determine critical parameters for processes.
      • Has basic knowledge of the key scientific, technical, and regulatory challenges associated with the manufacture of non-sterile pharmaceutical solid and liquid oral-dosage-forms.

Keywords: Randstad USA, Fort Worth , Validation Scientist, Other , Fort Worth, Texas

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