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Trinity Consultants - Advent Engineering · 3 weeks ago

Process Validation Engineer

Oakland, CA

Full-time

Onsite

Senior Level

5+ years exp

Trinity Consultants - Advent Engineering is an engineering and consulting firm that specializes in the pharmaceutical and biotechnology industries. The Process Validation Engineer will work with a team of engineers to support the validation of new product introductions and ensure compliance with process and cleaning validation principles in biologics manufacturing facilities.

ConsultingInformation TechnologyLegal

Hiring Manager

Ana Bonilla

Responsibilities

Review and contribute to process descriptions and process risk assessments to identify critical process parameter ranges and critical quality attributes

Develop process performance qualification protocols, validation rationale, sampling plans, and acceptance criteria

Execute process validation protocols along with engineering or PPQ runs

Summarize QC assay results in the form of a validation summary report

Develop cleaning validation protocols, assess worst case soiling material, define dirty hold and clean hold times

Develop cleaning validation sampling plan and sampling assays with acceptance criteria based maximum allowable carry-over calculations

Execute mock soiling, observe and document automated cleaning cycles, obtain final rinse and swab samples

Analyze QC assay results and document cleaning validation cycle parameters, clean and dirty hold times

Qualification

Process ValidationBiologics ExperienceTechnical WritingAutomation EngineeringCleaning ValidationCell TherapyGene TherapyRisk AssessmentQC Assay Analysis