The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices
Job Summary
The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices.
Ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.
Establish effective working relationships with Quality, IT, Lab Systems, Procurement, and others by developing new partnerships to identify continuous improvement opportunities of site validation practices.
Matching Summary
The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices.
Skills & Requirements
Must-have
Computerized System Validation (CSV)
cGMP regulations
21 CFR Part 11
EU GMP Annex 11
Data Integrity principles (ALCOA+)
Emerson DeltaV
OSIsoft PI
Siemens PLCs
Nice-to-have
Inclusive Leadership
Developing Others
Innovation
Process Improvements
Lean Supply Chain Management
Key Requirements
Minimum 6+ years experience in GMP manufacturing
Minimum 2 years experience in GMP Execution Systems, Automation, or IT
MES (preferably Werum PAS-X) and DeltaV Batch Control experience
Experience in supervision/management of people and resources