Process Engineer - Biotechnology

Harris Group Inc. is seeking an experienced individual with a minimum of 5 years in the biopharmaceutical industry to join our Westlake Village, CA office team. Candidates must have relevant experience in the design and/or operations of major biopharmaceutical unit operations such as fermentation, cell culture, chromatography, and filtration systems. Experience with typical biotechnology utility systems is also desired. Experience with commissioning and validation (IQ, OQ, PQ), cGMP requirements and change control is an advantage. Design experience should include utility operations and sequence of operations for typical biopharmaceutical production as well as familiarity with Process Flow Diagrams (PFD) and Piping and Instrument Diagrams (P&ID).

Specific areas of design capability include:
• Bioprocessing systems: equipment for fermentation, chromatography, ultrafiltration, WFI, purified water USP26, chemical batching, fill and finish
• Utility support systems: chilled water systems, utilities, high purity gases, CIP, SIP

This position requires a proven capability to complete chemical process projects:
• Prepare feasibility studies
• Develop project requirements by working with multiple customer stakeholders
• Develop design deliverable
• Manage budget, scope, and schedule
• Coordinate work with equipment vendors and contractors

The successful candidate will be filling a variety of engineering roles in support of customer operations including project/process engineering for new process equipment acting as the owner’s engineer. Detailed process and equipment/system design and project execution will be a significant effort. The candidate will be expected to work on multiple projects simultaneously. Experience in an operating facility working with internal customers would be helpful. The ability to work independently is critical.

The position is for a senior level process/project engineer but candidates at lower to mid level with appropriate experience will be considered. The candidate should have a minimum of a bachelor's degree or equivalent in biochemical, chemical or mechanical engineering.