Job Title: Associate Engineer, Drug Product Manufacturing - (JP10723)Location: Thousand Oaks, CA. 91320Employment Type: ContractBusiness Unit: DP Process and Equipment CapabilitiesDuration: 3 years (with possibility of conversion to permanent)Posting Date: 08/24/22Notes: Only qualified candidates need apply.3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:As a member of the process development team, this role will be focused on characterizing new fill finish technologies and advancing the state of the drug product manufacturing process at our client. The candidate will be primarily responsible for executing filler characterizations studies using complex fillers organizing data and analyzing results with minimal supervision. The candidate will establish the experimental design, develop, and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.Engineer responsibilities include, but are not limited to, the following: Independently design and execute experiments in order to characterize and enable implementation of new capabilities such as filling, lyophilization and analytical technologiesServe as single point of contact and subject matter expert (SME) on complex capabilities.Own business process and responsible for maintaining line time request forms and metricsApply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materialsConduct analysis of data generated from any of the above listed activities, including statistical analysis using SAS, JMP etc., and effectively communicate resultsTroubleshoot malfunctioning equipment, work with system owners, Asset Management, Facilities and vendors to repairAuthor/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating proceduresPerform tasks related to safety and compliance initiatives in the lab.Manage procurement and inventory levels of commonly used lab supplies and chemicalsManage dynamic project schedules and timelinesWhy is the Position Open?Team need for increased workloadTop Must Have Skills: Self-motivatedFamiliarity with large molecule processing operations / biotechnology productionTechnically capable and willing to learn.Familiarity with Teams/ Sharepoint administration is a big plus.Day to Day Responsibilities: Support operation of commercial grade fillers and equipmentScheduling, data analysis, coordination of operating activities to enable development filling experiments.Writing, reviewing, and developing procedures, formal data summary reports, and SOPs for routine operation.Preferred Qualifications: B.S. with 2‒3 years of industry experience, M.S. with 1‒2 years' experience, with degree in EngineeringPrevious experience in drug product/ drug substance manufacturing or process development labsKnowledge of and hands-on experience with various drug product technologies, particularly filling technologyDisplayed critical thinking, problem solving and independent research skillsAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policiesGood computer and organizational skills with strong attention to detailExcellent communication (oral and written)Excellent project management skills including the ability to manage project resource requirements material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-managementSelf-motivation, adaptability and a positive attitudeAbility to work independently and as part of a team with internal and external partnersExperience working in GMP environments or process developmentLight to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glassesEmployee Value Proposition:Career, growth, opportunity.Red Flags: Excessive short-term positions in multiple companies in a short time windowCandidate searching to apply for higher education in the next 1-2 yearsCandidate should have consistent industry experience (preferred)Interview process:Virtual Phone Interview (30min - 1 hr)Either Virtual Group Phone Interview (2 hr - 3 hr) OR In-person interview (2 hr - 3 hr), depending on COVID protocols, etc.We invite qualified candidates to sendyour resume to resumes@3keyconsulting.com . Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.#J-18808-Ljbffr