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!!