Production Tech-Pharm 3

Job description

Locations:Newark, Delaware
Job Family:Manufacturing

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Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 234936
Primary Location: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Entry level
Education Required Level: Bachelor's Degree
Travel Required: No

Division Description:

siemens

Job Description:

Specific Requirements:

Bachelor degree (advanced degree preferred), or equivalent required on one or more of the following fields: Biochemistry, Biology or Chemistry.Designs and/or develops antibody pools from raw bleed material to meet existing and revised specifications and claims.The candidate is responsible to manage polyclonal production process for multiple assays on different product lines.Leads, writes and/or executes validation protocols for equipment, software, and processes.Revises worksheets and SOPs relating to material lot changes.Uses excel spreadsheets and statistical software to analyze data relating to material qualification process and assay performance analysis.Leads technical meetings, interprets and presents data for cross-functional discussions regarding polyclonal antibodies and sub-assemblies.Design experiments and performs semi-complex calculations for establishing claims.Manage complex production schedule including immunization, collection, and qualification of material to ensure completion within expected parameters and time frame.Successfully applies knowledge and experience to interpret and present data, lead investigations, lead meetings, and troubleshoot complex problems.Knowledge and experience include: materials handling (bio and chemical hazardous materials and controlled substances), manufacturing, Lean Principles, working knowledge of modern analytical tools, principles for chemical and physical identifications and purifications

Major Functions and Responsibilities:

The functions will be in the area of biochemistry and diagnostics chemistry in an Operations environment.The candidate will be expected to develop, plan, execute, and functionally direct project(s) with complex features.The candidate may perform and/or oversee all aspects of manufacturing and project work to ensure completion within expected parameters and time frame. Results will be communicated to peers and management via standard written and oral means.All technical functions of an operations organization may be expected.Examples are, but not limited to:preparation and validation of written standard procedures for various existing and new manufacturing processes, 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, statistical sampling, Design of Experiments, data analysis, and technical support of procedures & processes.The candidate may directly or indirectly interact with other scientists, engineers, quality assurance and management.The individual will be expected to understand and comply with the Quality System Regulation in order to meet all FDA, ISO and IVDD standards.

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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Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more,Click here .

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