Engineer

Thousand Oaks, CA 91320

Posted: 06/20/2024 Job Number: 39344

Job Description


Engineer


Top 3 Must Have Skill Sets:
  • Masters Degree HIGHLY PREFERABLE
  • 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

Red Flags:
  • No pharma experience
  • Must have experiment experience
  • Good work ethics
  • Punctual
  • Not an entry level role **

Summary:

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 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 our 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.

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

Basic Qualifications:
  • Master’s degree

OR
  • Bachelor's Degree and 2 years of relevant experience
OR
  • Associate degree and 6 years of experience
OR
  • High school diploma / GED and 8 years of experience

Preferred Qualifications:
  • Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology correlated technical field of study in biotechnology, life sciences or related discipline.
  • Knowledge in scientific principles of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
  • Ability to work on multiple projects simultaneously, learn new techniques, keep accurate records, follow SOP’s and instructions in compliance with company policies, and comfortable to operate in a very flexible, agile environment
  • Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports.
  • Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with some oversight
  • Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
  • Demonstrated ability to use interpersonal skills to build strong technical relationships.
  • Self-motivation, adaptability, and a positive attitude.
  • Excellent communication skills, both oral and written.

 

Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.