SQA Solution South San Francisco, CA, United States
Mar 28, 2017Contractor
**** This is 8 month contract. W2 Only. No C2C**** The IT Validation Engineer or Specialist will be responsible for working closely with partners from USMA IT and Business Quality as well as USDS. Experience at senior level is required . Duties: Analyzes the validation impact of changes through risk assessment and helps in formulating the validation strategy for changes to existing or new computer systems and infrastructure. Creates qualification and validation deliverables, such as validation protocols, data migration plan and summary, etc., for new functionality, enhancements, maintenance releases and periodic reviews. Identifies and coordinates activities and tasks required to complete qualification and validation activities, including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests). Works with cross-functional teams, such as Operations, Business Quality, etc., to ensure that the applicable regulations, guidelines and internal procedures related to validation of computer systems and associated infrastructure are followed and applied during all stages of the defined software development life cycle (SDLC), project phase activities and audit and documentation management. Collaborate with multiple stakeholders from various functions across Pharma Informatics to identify cause and resolve major incidents and coach others to approach problems systematically Collaborates in the development of metrics and comprehensive reporting of incident management to support effective application of continuous improvement. Skills: 8+ years of qualification and/or validation experience in a GxP Validated environment Formal training and proficiency in software development methodologies and computer systems validation in regulated industries (biotech/pharma) Strong oral and written communication skills Proficient invalidation process methodologies, risk management, etc Good understanding of the standard project and SDLC methodologies Ability to assemble, analyze and evaluate data and to be able to make appropriate and well-reasoned recommendations and decisions to the Business stakeholders and team members Must be able to manage multiple tasks and be able to work independently Must be able to accept unexpected assignments as needed Customer focus and being a team player are a must Strong desire to learn and adapt Effective experience in supporting infrastructure qualification/validation and working with global teams is a plus Education: Bachelor’s degree in Computer Science or a related discipline or equivalent experience preferred.