Role: CSV Remediation Engineer
Location: Caguas, Puerto Rico
Job Type: Contract
Roles and responsibilities:
· CSV
· Documentation
· Pharma experience
· Manufacturing experience and knowledge
Job Description:
· Knowledge and strong understanding of Regulatory environments
· Hands on experience in IT processes in pharmaceutical manufacturing
· Sound understanding of 21CFR part 11 guidelines and GMP processes
· Generate and review CSV deliverables in compliance with 21CFR Part 11 and GxP FDA Compliance Regulations
· Hands on experience in creating/reviewing compliance lifecycle deliverables
· Follow Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP FDA Assessment
· Should have good knowledge and experience in writing specifications and trace matrices
· Authoring and execution reviewer of the project cycle for the new server installation including; User requirements, SAT, IOQ, Data integrity and Traceability Matrix. Investigation of project issues and change controls
· Good understanding of compliance documents across SDLC. Plan and execute validation activities independently, drive the team to perform test management activities in an automated environment
· Conduct risk assessment
· Design, develop and execute validation protocols (IQ/OQ/PQ), validation reports, and commissioning documents on both equipment and Lab systems
· Assist in planning and documenting validation project plan, review engineering reports and risk assessment to identify gaps and recommend necessary development
· Validation execution and line start up.
· Author of URS, FDS, FAT and SAT documents and project deliverables documentation.
· Investigation reports (CAPA) project issues (serialization system, labelers and Cartoner)