MSAT Process Engineer II *PC 544
$120,988–$142,405 year
On-siteSan Jose, California, United States
Job Summary
Assist in technology transfer activities from process development to manufacturing, including preparation of documentation and support during execution. Manage Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls. Coordinate the development, writing, collaboration, and review of Standard Operating Procedures, Batch Production Records, and other GMP documentation. Investigate and troubleshoot process deviations, non-conformances, and equipment issues, while participating in root cause analyses and implementing corrective actions. Analyze process data to identify trends, drive improvements, and ensure control strategies are effective. Provide technical support during audits and regulatory inspections, and contribute to lifecycle management of processes including scale-up and supplier qualification. Collaborate cross-functionally with QA, QC, Validation, and Manufacturing teams to ensure compliance with cGMP and Quality Management systems. Prepare periodic reports and present data to internal and external stakeholders.
Required Qualifications
- Bachelor's degree in these same disciplines
- Minimum of 5 years of relevant and progressively responsible experience in these same areas
- Master's in science/chemical engineering or related field
- Minimum of 3 years of progressively responsible experience in biologics/gene therapy manufacturing, MS&T or AS&T roles
- At least 5 years of related experience in a GMP biologics manufacturing environment
- Previous GMP experience in handling deviation, change controls, CAPA using appropriate quality system
- Excellent oral and written communication skills
- Strong technical writing ability
- Ability to work cross functionally within the organization as part of a project team
- Work experience in biologics for late-stage and commercialization of products with a good understanding of GMP operation
- Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines
- Experience in using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required to evaluate trends
- Must have ability to handle more than one task at a time
- Must work at a rapid pace while maintaining attention to detail
- Must occasionally lift and/or move up to 25 pounds
- Close vision
- Color vision
- Peripheral vision
- Depth perception
- Ability to adjust focus
Desired Qualifications
- Prior cell therapy experience
- Involvement in prior manufacturing process tech transfer
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