Genentech·11 days ago
11 days ago
Principal/Senior Principal Validation Engineer
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What you'll do
- Leading the development and execution of validation strategies for high-speed PFS assembly, packaging, and related facilities
- Overseeing lifecycle validation, regulatory compliance, and technical leadership in a fast-paced, innovative environment
What they're looking for
- validation strategy development
- fda 21 cfr part 4
- fda 21 cfr part 820
- iso 11607
- eu annex 1/15
- project management
- equipment qualification
- change control management
- deviation management
- risk management
- sop writing
- sampling plan development
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Take on the role of Principal/Senior Principal Validation Engineer, leading the development and execution of validation strategies for high-speed PFS assembly, packaging, and related facilities. Oversee lifecycle validation, regulatory compliance, and technical leadership in a fast-paced, innovative environment. Ideal for experienced professionals in drug product manufacturing and validation.
Skills
- validation strategy development
- fda 21 cfr part 4
- fda 21 cfr part 820
- iso 11607
- eu annex 1/15
- project management
- equipment qualification
- change control management
- deviation management
- risk management
- sop writing
- sampling plan development
- ppq protocols
- regulatory submissions
- technical leadership
- process improvement
- automation engineering
- quality assurance
- cross-functional collaboration
- mentorship
- recipe development
- technology transfer
- commissioning
- performance qualification
- new product introduction
Company
Genentech
Holly Springs, United States of America
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