Associate Engineer – Thermal Packaging Systems / Cold Chain Logistics / GMP Documentation & Project Support3Key Consulting is hiring an Associate Engineer – Thermal Packaging Systems / Cold Chain Logistics / GMP Documentation & Project Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.The Associate Engineer position is part of the Thermal Engineering Systems (TES) group at our client's Thousand Oaks, CA. facility. This role is responsible for supporting TES project management and documentation activities.
Under the guidance of senior staff, the individual will apply engineering principles and adhere to current SOPs to support the design, qualification, and implementation of thermal packaging systems. In addition, the role includes assisting with transportation laboratory testing, conducting experimental studies, and documenting results in compliance with SOPs.Top Must Have Skills:Knowledge of GMP-Bio/Pharma backgroundProject management and documentationProven written and oral communication skillsDay to Day Responsibilities:Track TES project progress and update project dashboardAuthor and revise controlled documents in document management systemAssist lab test execution and conduct characterization studies for TES projectsParticipate in shipping solution qualification projectsLead weekly team meetings to review project updates and facilitate team discussionsMaintain and update the SharePoint project management dashboard to track progressSupport shipping solution qualification projects and troubleshooting activitiesAssist with laboratory test execution, perform thermal experiments, analyze data, and generate reportsAuthor and revise controlled documents (SOPs, PCS, RPTs, APPXs) within CDOCS and PLM systemsCollaborate with cross-functional teams on protocol reviews, test preparation, change control processes, and deviation/CAPA managementUtilize MS Office Suite (Excel, Word, Visio, PowerPoint, etc.) to develop documentationBasic Qualifications:Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experienceBachelor's degree in engineering or a related science field (biotechnology, chemical, or mechanical engineering preferred)Prior laboratory experience and knowledge of pharmaceutical GMP/GDP practicesExperience with project management and GDocP (Good Documentation Practices) preferredStrong verbal and written communication skillsDemonstrated ability to execute engineering tasks in accordance with SOPs and established proceduresRed Flags:Candidates who lack relevant skillsCandidates who do not meet the qualification requirementsCandidates who were separated from previous employment due to unethical behaviorsInterview process: Phone interview followed by in person interview onsite