Title: Process Validation Scientist III
Location: Houston, TX 77047
Duration: 12 months
- Experience in troubleshooting issues related to manufacturing and/or testing products within a specialized area/technology.
- Ability to learn how to apply statistical methods and use statistical software. Ability to effectively communicate and document experimental results.
- Ability to develop experimental plans and write validation plans and reports within a specialized area/technology.
- 5-10 Year’s Experience.
- Develops validation plans, qualification protocols, compiles and anlyzes 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 set forth by 21 CFR 210, 211, 212, Part 11, ICH (Q7/8/9/10), EMA, and USP (relevant chapters).
- Represents PV on project teams and interfaces with customer technical and quality representatives.
- Represents Process Validation on internal teams (e.g. DRB, CCC, and Daily Management System meetings).
- Receives general instruction on routine work, detailed instruction on new assignments.
- Serves as the coordinator for quality Validation programs.
- Experienced with process validation (PPQ, CPV) and/or aseptic process validation.
- Supports requests for Proposals from customers and reviews Scope of Work to provide resource estimates.
- Performs other duties as assigned.
- Discrepancies: Able to work with minimal assistance and supervision on process validation discrepancies or investigations.
- Deviations: Able to assess deviations that affect product quality with minimal assistance.
- Change Controls: Able to lead change controls for new product/process into the Houston facility and assess major change controls with minimal assistance.
- CAPA: Able to work with minimal assistance and supervision on moderate CAPA that result from deviations, internal audits, protocol discrepancies, global quality audits or regulatory inspections.
- SOPs: Author / Review / Revise / Approve independently