What are the responsibilities and job description for the Biologics/Chemical Manufacturing Engineer position at ACL Digital?
Role - Biologics/Chemical Manufacturing Engineer
Location - Thousand Oaks, CA
Duration - 12 months contract
Description -
Manager is requiring that they have Biologics/Chemical manufacturing background. They would also like to see candidates that have conducted VISUAL INSPECTIONS' and 'Audit'
Preferred Qualifications:
• B.S. in engineering discipline with 1‒3 years’ experience or M.S. in engineering 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
Ideal candidate: The ideal candidate for this role should have a bachelor’s degree in any engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. They should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills. This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop over time.
Responsibilities include, but are not limited to, the following:
• 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 parameter risk assessments, process transfer documents, and change control assessments
• Support development and maintenance of technology transfer tools (clinical and commercial)
• Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
• Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
• 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
• Support at scale characterization and/or process validation runs as person in plant
Salary : $42
