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Process Quality Engineer

2 months ago

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

Key Responsibilities:
  • Validation Strategy Development: Formulate and execute validation plans that align with FDA and global regulatory standards, covering processes, equipment, and cleaning protocols.
  • Protocol Creation: Design and implement validation protocols (IQ, OQ, PQ) for various manufacturing systems and cleaning methodologies.
  • Process Enhancement: Drive continuous improvement initiatives to optimize manufacturing operations, aiming to boost efficiency, lower costs, and maintain high product quality.
  • Risk Management: Perform comprehensive risk assessments and devise strategies to mitigate potential risks associated with manufacturing processes.
  • Documentation Management: Ensure meticulous maintenance of validation documentation, including validation master plans, reports, and change control records.
  • Regulatory Adherence: Uphold compliance with current Good Manufacturing Practices (cGMP) and other pertinent regulations.
  • Cross-Functional Collaboration: Work closely with teams across Quality Assurance, Research and Development, and Production to foster process improvements and troubleshoot issues.
  • Issue Resolution: Analyze and resolve process deviations and quality concerns, implementing corrective and preventive actions as required.
  • Technology Transfer Support: Assist in the transfer of technology between development and manufacturing environments.
  • Training and Development: Educate production and quality teams on validation methodologies and industry best practices.
Qualifications:
  • Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or a related discipline.
  • Demonstrated experience in pharmaceutical process validation, including equipment, process, and cleaning validation.
  • In-depth understanding of cGMP regulations and FDA guidelines.
  • Strong analytical and problem-solving capabilities.
  • Familiarity with validation software and statistical analysis tools.
  • Excellent communication and teamwork abilities.
  • Detail-oriented with a commitment to quality and regulatory compliance.