LSC have a requirement for a QA Valdiation MES Associate to work in a high-performing, engineering team based with a multinational biotech manufacturing site based in Cork.
This position is responsible for the review and approval of the introduction of MES in a GMP regulated environment, this will involve the design and implementation of a MES system, and creating the validation strategy for implementation and working with IT-CSV on the validation documentation, and the execution of validation testing.
o Gather user requirements in relation to controlling and recording manufacturing activities
o Map existing manufacturing processes (warehouse, equipment management & EBR) to MES
o Design deployment and oversight of MES systems to replace paper based or manual systems in a pharmaceutical environment
o Oversight of the implementation of MES solutions and integration with ERP and control equipment
o Oversight of documentation of MES configuration and validation of EBRs
o Review and approval of validation lifecycle documentation.
EDUCATION AND EXPERIENCE:
o Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required.May serve as a subject-matter expert on specific cleaning verification/validation activities during regulatory agency inspections
o Minimum of 5 + years’ experience in a highly automated manufacturing or pharmaceutical environment
o Must have experience in implementing an MES solution (Werum, Rockwell, Emerson etc) as well as having experience in integrating these systems with ERP and/or control equipment
o Organizational and management skills to coordinate multi-discipline project groups
o Ability to speak, present data, and defend approaches in front of audiences and inspectors
o Knowledge of FDA and GMP guidelines a must
o Lead and represent Validation in multi-departmental meetings & project teams.
o Identifies and implements improvements to the QA Validation systems.
For full details on this role please contact Kathy on 021 4777329 or apply directly through this advert.