MSAT Process Engineer II *PC 522
$120,988–$142,405 year
On-siteSan Jose, California, United States
Job Summary
Conduct technology transfer from process development to manufacturing, authoring technical documentation and GMP batch records. Manage manufacturing quality events including deviations, CAPAs, and change controls while investigating process deviations and equipment issues. Coordinate Standard Operating Procedures and batch production records, analyze process data to drive improvements, and support process validation and qualification. Collaborate cross-functionally with QA, QC, and Regulatory teams to ensure cGMP compliance during audits and inspections. Prepare periodic reports for stakeholders and facilitate training to ensure effective process transfer.
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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