This role requires managing the complete Computer System Validation lifecycle for DeltaV processes within a biotech facility
Job Summary
This role requires managing the complete Computer System Validation lifecycle for DeltaV processes within a biotech facility.
The successful candidate will be responsible for generating configuration specifications, protocols, and summary reports while ensuring GAMP 5 and cGMP compliance.
Key responsibilities include executing thermal mapping activities, performing troubleshooting during tests, and documenting deviations or change requests.
Matching Summary
Match Score: 85
This role requires managing the complete Computer System Validation lifecycle for DeltaV processes within a biotech facility.
Skills & Requirements
Must-have
DeltaV programming knowledge
Computer System Validation lifecycle management
GAMP 5 compliance expertise
21 CFR Part 11 regulatory requirements
cGMP manufacturing practices
Protocol generation and execution
Thermal mapping activities
Nice-to-have
FDA CFR and EU health authority standards
Data logger usage proficiency
Strong analytical and organizational skills
Cross-functional team collaboration
Troubleshooting during test execution
Key Requirements
Diploma or Bachelor's degree in Computer Science, IT, Engineering, or Instrumentation
Minimum 3 years of experience in CSV within a biotech facility