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Validation Process Engineer

2 months ago

Durham, North Carolina, United States Katalyst Healthcares and Life Sciences Full time
Position Overview: As a key member of Katalyst Healthcares and Life Sciences, the Validation Process Engineer will play a crucial role in ensuring the integrity and compliance of our manufacturing processes.

Key Responsibilities:
  • Validation Strategy Development: Formulate and execute comprehensive validation strategies for processes, equipment, and cleaning protocols, adhering to FDA and global regulatory standards.
  • Protocol Creation: Design and implement validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for various manufacturing systems.
  • Process Enhancement: Drive continuous improvement initiatives to optimize manufacturing processes, enhance operational efficiency, and maintain high product quality.
  • Risk Management: Perform thorough risk assessments and establish effective risk mitigation plans for manufacturing operations.
  • Documentation Management: Ensure meticulous documentation practices, including validation master plans, reports, and change control records.
  • Regulatory Adherence: Uphold compliance with current Good Manufacturing Practices (cGMP) and relevant industry regulations.
  • Cross-Functional Collaboration: Work closely with teams across Quality Assurance, Research and Development, and Production to foster process improvements and address challenges.
  • Issue Resolution: Investigate process deviations and quality concerns, implementing corrective and preventive actions (CAPA) as required.
  • Technology Transfer Support: Assist in the transfer of technology between development and manufacturing environments.
  • Training and Development: Educate production and quality staff on validation methodologies and best practices.
Qualifications:
  • Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or a related discipline.
  • Demonstrated experience in pharmaceutical process validation, encompassing equipment, processes, and cleaning validation.
  • In-depth understanding of cGMP regulations and FDA requirements.
  • Strong analytical and problem-solving capabilities.
  • Familiarity with validation software and statistical analysis tools.
  • Exceptional communication and teamwork abilities.
  • Detail-oriented with a strong focus on quality and regulatory compliance.