Job Title: Engineer - (JP9325) Location: Thousand Oaks, CA. (10-25% onsite) Employment Type: Contract Business Unit: Commercial Drug Pproducts Duration: 1+ years (with likely extensions) Notes: Posting Date: 10/18/2021
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? Supplement additional workload on team.
Top Must-Have Skill Sets:
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
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
Knowledge of and hands-on experience with various drug product technologies
Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to elevate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude
Employee Value Proposition: To work for a dynamic team
Red Flags: Frequent job changes
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.