No H1B and/or C2C please!!

One of our leading Pharmaceutical client is looking for a Computer System Validation Engineer (Pharma/Biotech/GMP) , who is responsible for Responsible for authoring and/or revising the following documents related to GxP Systems.

Job Title: Computer System Validation Engineer (Pharma/Biotech/GMP)

W2 Contract & Onsite role

Location: Foster City , CA

Required Experience:- (5+ Years)

• Computer system validation using GAMP 5 methodology
• 21 CFR part 11 and Annex 11
• Change Control and Impact Assessments .

Summary:-

• Responsible for authoring and/or revising the following documents related to GxP Systems (specifically GE iFix & Rockwell FactoryTalk View based Environmental Monitoring Systems): User Requirements Specification, Functional Requirements Specification, Design Specification, Configuration Specification, Trace Matrix, Requirements Risk Assessment, Installation, Operational and Performance Qualification protocols. Responsible for execution of authored protocols.
• Author change management records, create or revise impacted documentation and execute change implementation tasks.
• Develop decommissioning and data migration strategies for legacy systems and author validation deliverables for decommissioning systems.
• Collaborate with cross-functional teams in authoring CAPAs and Deviations.
• Perform periodic system maintenance activities such as, account management, system maintenance, system audit trail review and backup and restore testing, etc.
• Maintain system specific operational documentation such as SOPs, work instructions, business-enabling documents, training plan as well as contribute to authoring and maintenance of business SOPs.
• Coordinate with IT stakeholders for maintenance of system infrastructure, security, and vulnerability management.
• Coordinate with business stakeholders to constantly align with their needs and deliver technical and compliant solutions, as required.
• Coordinate with software vendors for change deployment, scheduling of system maintenance activities and issue management.

If you are a right fit as per the skills requirements and this job excites you then please apply quick!!