Siemens Scientist 2 in Newark, Delaware
Job Family: Research & Development
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 224324
Primary Location: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
Siemens US Talent Acquisition
Skills and Qualifications:
The incumbent needs to possess good oral and written communication skills and be able to use software products to analyze data and prepare reports. Experience and knowledge in assay development is highly desirable. The typical candidate would have a BS or MS in Chemistry, Chemical Engineering, Biology, Material Science or related field with 1-3 years of experience. Extensive knowledge of Microsoft Excel is required. Demonstrates a basic knowledge chemical engineering and chemical &/or pharmaceutical processing equipment. Experience in biochemistry/immunology and clinical chemistry principles and skills working in a chemistry laboratory and work with potentially biohazardous materials are plusses. Candidate must be flexible and demonstrate the ability to change priorities to meet business
Work as part of a team with Siemens staff to support the manufacture of biochemical reagents, bulk reagents, calibrator and control products and other fluidic chemical compounds. The successful candidate will, as part of a product support team, need the ability to troubleshoot, product performance issues as well as manufacturing and/or supply chain issues. As part of the troubleshooting activities, the successful candidate will to be able to fully characterize (via suitably statistically designed parametric studies/experiments) the process capabilities of process steps constructed to produce the product and to use the output of those studies to establish manufacturing release and control limits as well as recommend testing schemes and protocols. The ideal candidate would also be able to contribute to process validation activities , be experienced with developing IQ, OQ and PQ validation protocols and then executing such protocols and have the ability to drive cross-functional PFMEA reviews and participate in process hazard reviews.
Key aspects will likely include exposure or ability to directly support the following objectives:
• Evaluation of process equipment to produce custom formulated liquid reagents as well as automated material handling equipment to label and package final product
• Physical/chemical characterization of product, metrology, performance testing and working with team to correlate impact of process parameters on end-use product.
• Documentation of processes, validations and authoring technical protocols, reports and testing procedures in a regulatory-compliant environment.
• Development of/or management of external partners that may produce critical raw materials
• Interpreting analysis of instrument-chemistry interactions for clinical chemistry methods to understand sensitivities of product to manufacturing processes.
• Lead and conduct troubleshooting activities as necessary to determine the root cause for failures and identify and verify corrective actions. Must be familiar with design change, design verification and validation requirements for products and processes. Should be able to plan and execute assay verification and validation studies.
Preferred Knowledge, Skills and Abilities, Experience:
• Project Management training and experience is a plus
• Should be knowledgeable about FDA and other external regulatory agency requirement including cGMP, familiar with safety aspects of biohazardous materials; provide technical support for regulatory submissions/registrations.
• Experience in experimental design, use of DOE and statistical analysis software and SPC is a plus.
• Relevant work experiences may include: In-vitro diagnostic or pharmaceutical product manufacture. manufacturing, compounding and processing of pharmaceuticals,
• Apply scientific and statistical principles and provide technical leadership to perform a wide variety of technical investigations arising out of reagent performance issues encountered during reagent manufacturing. Working knowledge of clinical chemistry and application of automated assays in clinical chemistry laboratories is a plus.
• Ability to build strong working relationships in cross-functional project teams to develop technical solutions to problems
• Manufacturing of clinical biologic reagents for FDA regulated diagnostics industry, utilizing & authoring procedures, managing bills of materials and meeting quality system requirements.
• Manufacture, support, and troubleshooting of IVD products.
• Practical integration of products/processes into an operations environment.
• The individual will be expected to understand and comply with the Quality System Regulation in order to meet all FDA, ISO and IVDD standards.
• The position may be expected to develop, plan, execute, and functionally direct project(s) with complex features. Position will oversee all aspects of project work to ensure completion within expected parameters and time frame.
• Results will be communicated to peers and management via standard written, oral, or visual means. Good skills are expected in: computers, customary MS Office programs, various types of communication tools.
• Practical knowledge and utilization of Lean Manufacturing processes.
• Position will be involved in but not limited to: preparation and validation of written standard procedures for various existing and new manufacturing process, troubleshoot performance and process deviations, and drive projects for all changes to standard procedures.
• Good scientific principles and practices are expected throughout, including but not limited to: documentation, statistics and statistical sampling, Design of Experiments, data analysis, technical investigations of procedures & processes and laboratory skills (operation, maintenance, & troubleshooting of analytical instruments and chemistry processes).
Direction of Others:
Position will be as an individual contributor – no personnel management experience is required, however there may be the responsibility to functionally direct other technical staff members and manage external contracted partners.
Key Working Relationships:
Primarily intra-organizational contacts with Siemens manufacturing and supply chain teams and relationships with external development &/or supply partners.
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
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Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .