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| Job Category : | Engineer |
| Company Name: | PSC Biotech |
| Position Name: | Senior Process Engineer |
| Location : | San Diego, CA 92101 |
| Job Description : | PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date. We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations. We are hiring a Senior Process Engineer to provide technical expertise and leadership for the characterization and design of high-volume manufacturing processes. The Senior Process Engineer will be responsible for troubleshooting and optimizing existing processes. The ideal candidate should be able to launch diagnostic test kits containing PCR reagents, lyophilized products, and custom plastic assemblies. Responsibilities Design, implement and optimize manufacturing processes in an FDA-regulated environment. Provide subject matter expertise in lyophilization, formulation, mixing and QC testing for chemical reagents such as enzymes, oligos and buffers. Provide support for the design of consumables, assembly architecture and strategies related to filling, capping, labelling, and kitting. Create capacity models based on forecasts for new products. Develop plans to ensure forecast can be met. Includes analysis of labor hours, space requirements, production batch sizes and production workflow. Create requirements and operating ranges for manufacturing equipment and other processes. Develop and execute risk-based validation strategies. Develop standards and tools to assist in the transfer of complex processes. Leverage expertise in process engineering techniques such as DOE’s, SPC, failure mode analysis, inspection variation analysis, Critical Parameter Management, and Design for Manufacturability. Work with critical suppliers on raw material requirements and develop internal and external test procedures. Establish BOM’s, work routings, and appropriate manufacturing specifications. Develop work procedures and train manufacturing personnel. Ensure existing processes adhere to quality standards while reducing overall production costs. Lead and participate in continuous improvement activities. Must be self-motivated with the ability to identify and drive process improvement opportunities into a regulated production environment. Must have a demonstrated ability to solve complex problems related to reagent chemistry, micro-fluidic devices or lateral flow devices. Excellent verbal and written communication skills required for reaching various levels within site organization. Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching – PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%. PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at 24 Hour Fitness Financial Perks and Discounts #LI-RW1 Previous experience transferring complex processes from lab benches to full scale production. Must be self-motivated with the ability to identify and drive process improvement opportunities into a regulated production environment. Must have a demonstrated ability to solve complex problems related to reagent chemistry, micro-fluidic devices or lateral flow devices. Excellent verbal and written communication skills required for reaching various levels within site organization. |
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