Senior Validation Engineer

4 days ago


Houston, Texas, United States Lonza Full time
About the Role

We are seeking a highly skilled Senior Process Validation Engineer to join our team at Lonza. As a key member of our process development team, you will be responsible for ensuring the quality and compliance of our biologics manufacturing processes.

Key Responsibilities
  • Process Validation: Develop and execute process validation plans, protocols, and reports to ensure compliance with regulatory requirements.
  • Regulatory Compliance: Ensure that all processes and procedures are in compliance with relevant regulations, such as cGMP and CGT.
  • Process Improvement: Identify areas for process improvement and implement changes to optimize efficiency and quality.
  • Team Collaboration: Work closely with cross-functional teams, including quality, manufacturing, and supply chain, to ensure seamless execution of processes.
  • Communication: Develop and maintain effective communication with clients, stakeholders, and internal teams to ensure clear understanding of process requirements and expectations.
Requirements
  • Education: Bachelor's degree in Chemical Engineering, Biochemical Engineering, or other Life Sciences degree.
  • Experience: 5+ years of experience in manufacturing, process validation, and regulatory compliance, with a strong understanding of cGMP and CGT regulations.
  • Skills: Strong technical writing skills, ability to interface with clients, and experience working with quality systems.
About Lonza

Lonza is a global leader in life sciences, operating across three continents. We are committed to improving lives through innovative solutions and a strong focus on quality and compliance.



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