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Global R&D Laboratory Systems Specialist

Company: The Estee Lauder Companies
Location: Melville
Posted on: May 16, 2022

Job Description:

**Global R Laboratory Systems Specialist****Brand:** Est--e Lauder Companies**Description**The primary role of this position is to effectively manage the R laboratory computerized systems, instruments and equipment.The individual is required to work with Corporate functions - Global R and Global QA - to ensure robust SOPs Work Instructions and maintenance schedules are in place to ensure complaint laboratory systems.The process scope includes managing+ Requirements for purchasing, install and qualification of new lab equipment and Introduction across all brands, regions and functions.+ Maintenance and calibration of existing lab equipment to ensure optimal performance+ Governance of process, access and documentation to ensure complianceThe geographic scope is Global and includes all R Laboratories at Melville (USA), Blaine (USA), Shanghai (China), Toronto (Canada).1. Responsible for managing all R Laboratory Instruments and Equipment1. Individual is responsible for technical management of all R laboratory data management systems used globally as well as equipment software in Melville (Research Park and Greenway). This would include: R System (RDS), Clinical Research Center databases and equipment software, Special Analytical Services equipment software, Physical Chemistry equipment software, Electronic Laboratory Notebook software, chemist bench scales etc.2. This responsibility includes working with individual scientific system vendors, and site/lab supervisors - in maintaining - system/instrument/equipment inventory, maintenance schedules, current compliant system documentation, compliant training procedures and documentation, etc. This responsibility also requires developing and documenting the "processes" for the Equipment/Instrument management.3. Provide leadership to ensure that all initiatives are appropriately and effectively managed, documented and monitored for optimum efficiency and effective roll out.4. Coordinate all system rollouts, scientific applications (laboratory informatics) and new system upgrades impacting the R labs.5. Coordinate with R supervisors and site QA to conduct periodic, hands-on audits and an annual physical inventory verification of computerized systems throughout R to ensure that systems are current and continue to function appropriately for current usage in Est--e Lauder6. Coordinate, execute and document all System User Access verifications for data integrity and compliance requirements. This would include an effective software license management for specialized computer software specific to R7. Ensure all GXP applicable systems have CSV (Computer System Validation) documentation and procedures in place8. Ensure all R systems have appropriate back up procedures1. Corporate IT has procedure are in-place for IT managed systems (e.g. RDS)2. R stand-alone computerized system backup procedures are in-place and periodically tested for non-networked systems.2. Works closely with the business stakeholders on business requirements, manages technical feasibility analysis, and financial analysis of proposed process and technical solutions.9. Leads and manages the effective execution and implementation of computerized projects in the R lab space.1. Ensure production releases meet business expectations and adhere to standards.2. Strong knowledge of Program Management, Project Management, Agile and SDLC/Release management processes.3. Effective communication with business stakeholders and project stakeholders.10. Ensures adherence to SDLC, FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detail knowledge of the R Quality Systems inclusive of Change Control, CAPAs and Deviation procedures.**Qualifications**?Experience in staff management with proven ability to manage and collaborate in a multi-location, multi-vendor environment with an emphasis on process documentation and training.?Experienced in R processes and systems in a Fortune 500 CPG company.?Experienced in managing R laboratory equipment and systems in a highly dynamic corporate landscape across multiple brands?Experienced in writing SOPS and Work Instructions and other Quality System Documents.?Knowledge of GXP (Good Clinical/Manufacturing/Documentation practices)?Knowledge of FDA Validation and CFR 21 Part 11?Knowledge of PLM applications and SAP ERP a plus**College graduate - BS****10 Years Experience****10% Travel****Job:** Research & Development**Primary Location:** Americas-US-NY-Melville**Job Type:** Standard**Schedule:** Full-time**Shift:** 1st (Day) Shift**Job Number:** 223591We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact USApplicantAccommodations@Estee.com

Keywords: The Estee Lauder Companies, New Haven , Global R&D Laboratory Systems Specialist, Healthcare , Melville, Connecticut

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