Process Validation Engineer II
Lonza
- Houston, TX
- Permanent
- Full-time
- Develops validation plans, qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure products are manufactured in accordance with applicable regulatory agencies, clients and Lonza specifications/requirements.
- Assures that all validation documentation meets or exceeds the regulatory expectations
- Represents Process Validation on project teams and interfaces with customer technical and quality representatives. Represents Process Validation on internal teams
- Serves as the coordinator for quality Validation programs.
- Experienced with process validation and/or aseptic process validation.
- Able to work with minimal assistance and supervision on process validation discrepancies or investigations.
- Able to assess deviations that affect process validation with minimal assistance.
- Able to lead change controls for new product/process into the Lonza Houston facility and assess minor change controls with minimal assistance.
- Able to work with assistance and supervision on moderate Corrective Action Preventive Action (CAPA) that result from deviations, internal audits, protocol discrepancies, global quality audits or regulatory inspections.
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering or other Life Sciences Degree.
- Experience in pharmaceutical, biotechnology, or related industry.
- Advanced understanding of Process Validation, Process Performance Qualification (PPQ), Continued Process Verification (CPV)
- Good Manufacturing Practice (GMP) compliance knowledge
- Experience working with quality systems
- The ability to interface and communicate directly with clients will be required.
- Strong technical writing skills