Hi,
I hope you’re doing well! I’m Rahul, a recruiter at Empower Professionals Inc., and I have a Validation Engineer position that might interest you. Let me know if you’re available to discuss further.
Role: Validation Engineer Locations: Foster City CA (Hybrid) Duration: 12+ Months
Must have: • Computer system validation using GAMP 5 methodology • 21 CFR part 11 and Annex 11 • Change Control and Impact Assessments
Responsibilities: • 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.
Requirements: • Minimum 5 years of experience working in an FDA regulated environment, validating computerized systems. System Administration experience is preferred but not required. • Must be experienced in computer system validation using GAMP 5 methodology. • Must have a good understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to environmental monitoring systems. • Experienced in developing validation methodology for global implementation of systems. • Experience with validation methodologies and SDLC best practices. • Proficient in current Good Manufacturing Practices (cGMPs) requirements.
Nice to Have: • Process Control Systems / Environmental Monitoring Systems technical proficiency Data Migration experience Project Management
I hope you’re doing well! I’m Rahul, a recruiter at Empower Professionals Inc., and I have a Validation Engineer position that might interest you. Let me know if you’re available to discuss further.
Role: Validation Engineer Locations: Foster City CA (Hybrid) Duration: 12+ Months
Must have: • Computer system validation using GAMP 5 methodology • 21 CFR part 11 and Annex 11 • Change Control and Impact Assessments
Responsibilities: • 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.
Requirements: • Minimum 5 years of experience working in an FDA regulated environment, validating computerized systems. System Administration experience is preferred but not required. • Must be experienced in computer system validation using GAMP 5 methodology. • Must have a good understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to environmental monitoring systems. • Experienced in developing validation methodology for global implementation of systems. • Experience with validation methodologies and SDLC best practices. • Proficient in current Good Manufacturing Practices (cGMPs) requirements.
Nice to Have: • Process Control Systems / Environmental Monitoring Systems technical proficiency Data Migration experience Project Management