Principal/Senior Principal Process Engineer, Aseptic Operations/Filling
$114,380–$256,750 year
On-site · Hillsboro, Oregon, United States
Job Summary
Lead and support tech transfers for aseptic filling at Genentech Hillsboro, collaborating with Manufacturing, QA, and Engineering Science & Technology to ensure regulatory compliance, process validation, equipment qualification, and successful tech transfer and NME launches. Responsibilities include leading technology transfers, protocol development, execution, report writing, preparing regulatory submission sections, mentoring junior engineers, and driving continuous improvement in aseptic processing. Requires BS/MS in Engineering or related field with 8+ (Principal) or 12+ (Senior Principal) years of pharma/biotech experience, strong knowledge of cGMP/regulatory requirements, data analysis skills, and effective cross-functional collaboration.
Required Qualifications
- BS/MS in Engineering, Pharmaceutical Sciences, or related field
- minimum years of relevant experience (Principal Engineer = 8+, Senior Principal = 12+)
- experience in pharma/biotech industry
- knowledge of pharmaceutical/biologics processing principles, cGMP, regulatory requirements (FDA, EMA)
- proficiency in data analysis and statistical tools
- excellent problem-solving and troubleshooting skills
- professional level communication and collaboration skills
- detail-oriented with commitment to compliance
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