• Agilent
  • San Francisco , CA
  • Electronics/Semiconductors
  • Full-Time
  • 23 Broadway

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Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
The Agilent CrossLab Group is looking for a Validation Consulting Specialist to deliver consulting services to our customers in the FDA regulated markets (i.e. Pharmaceutical, Biotech, Nutraceuticals, etc.). We are looking for an individual with a solid background in regulatory compliance as it relates to laboratory instrumentation systems. Experience in scientifically sound laboratory practices and quality assurance is desirable. Success in this role is ultimately measured by delivering the highest quality compliance consulting services to our customers.
You will deliver and manage compliance consulting projects focused on Computerized System Validation (GAMP 5 methodology) and Data Integrity assessment/remediation. You will need to stay current with related industry trends and regulations to be able to deliver the best in class services. Working with the Global Senior Compliance Consultant this role will provide customer specific validation services to meet the customer's requirements. Areas of consulting may include: Computerized System Validation, Audits/Assessments, custom procedure development, and Data Integrity assessments and remediation. Knowledge of US FDA 210/211, 58, 820 and 11; and the GAMP 5 risk-based approach to computerized systems validation are critical to success in this role.
This role will provide both remote and on-site (at customer facilities) support depending on the customer and project requirements and the nature of the specific work being performed. Estimated travel is 25 -- 50%.
You must have some project management experience and be able to meet project timelines and communicate across multiple laboratory, IT, and Quality departments.
The successful candidate must be able to:

Provide Computerized System Validation document authoring and execution services.
Provide Data Integrity assessment and remediation.
Manage compliance consulting projects
Provide project management updates to Customer and/or Global Senior Compliance Consultant.
Ensure customer requirements are met, and customer satisfaction attained.
Possess strong technical writing skills
Provide SOP writing services.
Communicate across diverse customer organizations (Scientific, IT, QA, Engineering, etc)
Coordinate with Global Senior Compliance Consultant for customer management and quality assurance of validation deliverables.
Escalate issues to CSO management and Global Senior Compliance Consultant.
Achieve insights to customer's needs in the regulated industries
Stay current with applicable regulatory trends and regulations

This role is dedicated to improving our customer loyalty and satisfaction.

Associated topics: asic, cad, cadence, circuit, engineer iii, h/w designer, h/w engineer, layout, schema, systems engineer

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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