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Validation Specialist in Fort Worth, Tx

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Validation Specialist at Katalyst Healthcares & Life Sciences

Validation Specialist

Katalyst Healthcares & Life Sciences Fort Worth, TX (Onsite) Full-Time
  • A VSp. is familiar with site compliance related functions for validation activities (e.g., Process Validation, IQ OQ PQ Validation, Computer System Validation (CSV), Method Validation).
  • Performs various testing procedures in support of validation project execution for equipment, critical utilities, automated systems, software, cleaning validation, and process validation according to written SOPs and protocols.
  • Participate in Risk Analysis within the documented Risk Management System for Validations.
  • Ensures that their execution of protocols, records, and procedures is compliant with current Good Manufacturing Practices (cGMP), Good Automated Manufacturing Practice (GAMP), and Sovereign's SOPs.
  • Able to read and understand specifications (design requirements, functional requirements, and user requirements), trace matrices, validation summary reports, and test protocols for installation, operation, and performance qualifications.
  • Familiar with regulations and guidances (e.g., 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, ICH, ISPE, PDA, MHRA, PICs).
  • Versed in the concepts of data integrity and statistical treatment of experimental data. Can, with supervision, recognize laboratory data that is compliant to applicable regulations and meets study protocol acceptance criteria.
  • Able to summarize experimental data for populating technical reports..
  • High School Diploma or General Educational Development Test (GED) with at least six years of pharmaceutical manufacturing experience and three years of validation, qualification, and commissioning experience in the pharmaceutical industry are required.
  • Demonstrated experience with the 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.
  • Knowledge of FDA Current Good Manufacturing Practices (cGMP) and Good Automated Manufacturing Practices (GAMP) requirements.
  • Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint).
  • A Two-year technical degree (e.g., Associate in Science) with three years of experience in areas of validation, qualification, and commissioning in the pharmaceutical industry. A Bachelor of Science Degree in Chemistry or Engineering.
  • Certification is a plus (e.g., ASQ CQE).
  • 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.

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