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Engineer II
Ref No.: 18-08974
Location: Oceanside, California
Engineer II
Onsite in Oceanside, CA
12 month contract
W2 Only

-This position is in the PTI /Global Biologics Manufacturing Science and Technology group, which supports GMP manufacturing of pharmaceutical products at internal Client and External CMO and partner sites.
-This position will primarily focus on leading cross-functional projects, troubleshooting manufacturing and supplier issues, and aligning technical experts to define best practices for Single-Use Technologies (SUT) across the Global Biologics Manufacturing Network.
-In this position, you will need to provide scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients.
-Integrity, accountability, and strong dedication to the patients we serve are critical to this role.
-Full working knowledge and experience with Single-Use equipment qualification, design and operation is highly preferred, although not required.
-Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
-Lead and/or participate in global initiatives and cross-functional investigation and project teams
-Work collaboratively with Global Manufacturing Science and Technology (gMSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network
-Development of database and business process for management of vendor extractable data packages for materials of construction
-Evaluate current state and recommend improvements and modifications to data management systems based on voice of customer surveys
-Create a platform for calculation of extractable and leachable impurities
-Create a repository for qualified film information & data packages
-Assist with organization and management of documents including department reports, memos, and supporting raw data
-Create business process and for document management, including unique identifiers, version control, storage, etc.
-Review data packages and compare to industry guidelines and internal acceptance criteria
-Work with Operational Excellence to design business process for new and existing materials of construction (MOC) item requests
-Work as the Business Process Owner for vendor data package information intake and assessment
-Develop training materials and provide training sessions as needed

-BS/MS/PhD. in Chemical/ Biochemical Engineering or Life Sciences with at least 4 years of relevant industrial experience or academia (including advanced studies) after receiving Bachelor's degree
-Self-motivated, able to work independently as well as in teams. Excellent organizational and communication skills (both written and verbal)
-Demonstrated proficiency in leading teams, experience leading cross-functional or cross-site teams is a plus
-Proven ability to influence beyond direct line reporting relationships including to senior management
-The use of personal computer hardware, software and peripherals
-Proficient in the use of Google apps (e.g. gMail, gCal, gSites, gDocs)
-Various programming techniques (e.g., HTML, JavaScript, XML)
-Database management and understanding of knowledge management principles
-Strong analytical and problem solving capabilities
-Full working knowledge and experience with Single-Use equipment qualification, design and operations is a plus
-SAP experience is a plus
-Perform financial analyses for new and existing facilities
-Assess cost of goods (COG), return on investment (ROI), and net present value (NPV) for stainless steel systems as compared to SUT retrofits using financial modeling software (e.g. BioSolve)
-Develop analyses for customers developing business cases
-Maintain an internal database of existing analysis results
-Develop training materials and provide training sessions as needed