Details: Requisition Title: Process Engineering & Validation Expert Location: Carlsbad, CA 92009 Duration: 12 months
Duties: Responsible for the equipment inside clean rooms, advanced equipment - specifications, how equipment interfaces with the process. Biotech - equipment - process Experience: The more the better but also willing to look at junior candidates, bio-tech experience, change controls, GMP documentation Education: Bachelor's in Engineering or Science 1 year potentially temp to perm Description: The focus of the Process Engineering role is on ensuring manufacturing equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. Responsibilities of the Process Engineering function include both tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.
The role reports into the Manufacturing department at the site. The engineer is responsible to support the development of scope, design, client interface, cost and schedule development, project reporting, construction oversight, construction safety, procurement, start-up scheduling and execution, and managing validation interfaces on assigned capital projects. Acts as Subject Matter Expert in a specific technical area with responsibilities to train and support users, troubleshoot and resolve operational problems, and process improvement projects. This position takes supervisory direction but sets their day to day activities.
A qualified candidate should be familiar with the biotech process of thawing and expanding cell cultures, purifying product with TFF and column chromatography, and sterile filtration. Additionally the candidate should be familiar with operations in an ISO 7/8 cleanroom.Equal Opportunity Employer: E claro values diversity anddoes not discriminate based
