Job Description :
Sr. Computer System Validation Engineer
Location: Emeryville, CA
Duration: 12+ months
Job Description:
We are seeking a Senior Computer Systems Validation Engineer who will be reporting into the Director or Enterprise Applications. This person will plan, author, implement and maintain computerized system validation for the business systems used to support regulated activities (i.e. GxP, SOX The Senior Computer Systems Validation Engineer will collaborate with IT and Quality staff to develop consistent validation strategies, implement and improve standards for IT change management and collaborate with the IT
PMO to define resource allocation and validation timelines.
Lead the development of IT validation strategies in close collaboration with Quality.
Identify and implement improvements to existing validation processes.
Deliver guidelines, templates and training to IT staff for IT change management and validation efforts.
With the IT PMO define standard validation timelines and appropriate resource allocation.
Gather and documents user requirements from business stakeholders to establish intended use of computerized systems.
Author validation deliverables in collaborate with project stakeholders to (e.g. IQ, Validation Plan, Test Plan, Test Scripts, etc
Manage validation activities of cross-functional teams to ensure validation effort is executed to plan and properly documented in the appropriate validation documents.
Support resolution and documentation of protocol and test discrepancies.
Ensure validated systems remain in compliance with applicable regulations and internal procedures as changes to the systems are made.
Maintain computerized system validation documentation.
Professional Experience:
Experience in GxP regulated industry
A minimum of 8 years in direct hands-on experience validating GxP Computerized Systems
Advanced knowledge of GxP regulations and approaches to System Life Cycles (SLC) and GAMP
Excellent written and oral communication skills.
Strong planning, organizing, and execution skills.
Ability to proactively manage workload and meet deadlines.
Develop and implement creative solutions to improve processes.