59 applicantsPosted by Agency
EPITEC · 6 days ago
Process Engineer
Thousand Oaks, CA
Contract
Onsite
Mid Level
2+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesInformation TechnologyStaffing Agency
Hiring Manager
Marsha Biles
Insider Connection @EPITEC
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), including make-a-batch exercises, process transfer documents, and change control assessments
Support the 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
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Master’s degree OR Bachelor's Degree and 2 years of relevant experience
Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline
Knowledge of cGMP and experience in drug product / drug substance manufacturing or process development in pharmaceutical industry
Hands-on experience with various drug product technologies
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
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
Preferred
Masters Degree
Familiarity with cGMP
Experience in drug product / drug substance manufacturing or process development in pharmaceutical industry setting and manufacturing
Company
EPITEC
Epitec is a premier technology services and professional staffing company.
1,001-5,000 employees
H1B Sponsorship
EPITEC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (121)
2022 (183)
2021 (244)
2020 (284)
Funding
Current Stage
Late StageLeadership Team
Mark Ruma
Chief Operating Officer (COO)
Company data provided by crunchbase
