Job Title: Engineer, biopharma process engineering (JP10263) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit: Production Support Duration: 1+ years (with likely extensions) Notes: Only qualified candidates, please. Mostly onsite in Thousand Oaks, CA. (hybrid) - need to be local. Posting Date: 05/16/22
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple client products to various aseptic fill finish manufacturing plants and production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of client products. The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.
Why is the Position Open? Planned project/ team need
Top Must-Have Skill Sets:
B.S. in engineering or biotechnology discipline with 1‒3 years’ experience or M.S. in engineering or biotechnology discipline with 0‒2 years’ experience.
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development in pharmaceutical industry setting and manufacturing.
Knowledge of and hands-on experience with various drug product technologies.
Day to Day Responsibilities:
Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials.
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process transfer documents, and change control assessments
Support development of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
Development of digital tools and models by leveraging data analytics and programming skills
Employee Value Proposition: Unique lab experience and opportunity.
No pharma experience
Must have experiment experience
Not an entry level role **
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you 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 www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.