Verified Job
Engineering - Architecture
Senior Validation Specialist or Engineer
Engineering - Architecture
#824680
Remote / WFH
ivy works
Job Description
IVY Works has an opening for full time employee as a Computerized System Validation Specialist or Engineer
Responsibilities
• Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
Experience
• Bachelor's degree in engineering / science.
• 4-6 years of work experience is a must.
• 3+ years of experience/exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• Good communication and technical writing skills are a must.
• Project Management experience
Responsibilities
• Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
Experience
• Bachelor's degree in engineering / science.
• 4-6 years of work experience is a must.
• 3+ years of experience/exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
• Good communication and technical writing skills are a must.
• Project Management experience
