Associate Engineer, Drug Product Manufacturing - (JP10723)

Job Title: Associate Engineer, Drug Product Manufacturing - (JP10723) Location: Thousand Oaks, CA. 91320 Employment Type: Contract Business Unit: DP Process and Equipment Capabilities Duration: 3 years (with possibility of conversion to permanent) Posting Date: 08/24/22 Notes: 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 technologies Serve 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 metrics Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials Conduct analysis of data generated from any of the above listed activities, including statistical analysis using SAS, JMP etc., and effectively communicate results Troubleshoot malfunctioning equipment, work with system owners, Asset Management, Facilities and vendors to repair Author/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures Perform tasks related to safety and compliance initiatives in the lab. Manage procurement and inventory levels of commonly used lab supplies and chemicals Manage dynamic project schedules and timelines Why is the Position Open? Team need for increased workload Top Must Have Skills: Self-motivated Familiarity with large molecule processing operations / biotechnology production Technically 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 equipment Scheduling, 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 Engineering Previous experience in drug product/ drug substance manufacturing or process development labs Knowledge of and hands-on experience with various drug product technologies, particularly filling technology Displayed critical thinking, problem solving and independent research skills Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Good computer and organizational skills with strong attention to detail Excellent 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-management Self-motivation, adaptability and a positive attitude Ability to work independently and as part of a team with internal and external partners Experience working in GMP environments or process development Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses Employee Value Proposition: Career, growth, opportunity. Red Flags: Excessive short-term positions in multiple companies in a short time window Candidate searching to apply for higher education in the next 1-2 years Candidate 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 View email address on click.appcast.io . 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 website You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role. #J-18808-Ljbffr 3key Consulting, Inc.