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