Aptask Global Workforce (AGW) is seeking a Process Development Engineer for a Hybrid position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 12+ month contract opportunity. Summary: This role supports the process development team by focusing on the development and characterization of drug product technologies and manufacturing capabilities. The ideal candidate will assist in process validation and technology transfer of products to aseptic fill-finish manufacturing plants. This position combines project development and project management skills with a focus on meticulous documentation and deadline adherence within a cGMP environment.
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 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)
- Support development and maintenance of technology transfer tools
- Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
- Author, review, and data verify technical documents, such as technical protocols, technical assessments, and technical reports
- Conduct analysis of data generated, including statistical analysis
- Support at scale characterization and/or process validation runs as person-in-plant
Requirements: - Bachelor's degree in a scientific or engineering discipline with at least 1 year of industry experience
- Master's degree in a scientific or engineering discipline is also acceptable
- 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
- Excellent project management skills
- 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
Desired skills: - Experience with software tools such as SAP or Smartsheet
- Experience with statistical analysis using Minitab, JMP, etc.
- Experience in the development of digital tools and models by leveraging data analytics and programming skills
Pay range: up to $42.52 per Hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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