Description

CSV Engineer needed to support a major project that encompasses the configuration and implementation of multiple systems for a new manufacturing site which will require software validation of ERP, MES, LIMS, AMS, and the related integrations.

Key Areas of Accountability / Responsibility

You are the dedicated resource responsible for designing, creating, planning and executing the site validation plan for all GxP computer systems and software to be implemented at the new Client Biomedical Devon site project.

The validation shall align with global regulation requirements, meet the requirements of the procedures for computer system validation and assurance, and guide decisions around the direction of the validation plan for the new site

Lead software validation implementation and any additional QA requirements through effective planning of set up, design and testing for the project

Create, modify, and organize all related and required documentation for the validation of the software and computer systems for the project

Work with project team to document user requirements

Work with vendors to collect functional specifications

Modify, amend previously executed validations for the existing systems as needed

Work with the business and vendors to create test scripts and coordinate with the team to execute the testing

Deliver validation final report out for each system implemented and full site go-live

Computer System Validation (CSV) of the following software applications for GMP use at the Devon plant.

Laboratory Information Management System (?LIMS”) – existing SampleManager

Enterprise Resource Planning (“ERP”) – existing SAP

Asset Management System (“AMS”) – New system

Manufacturing Execution System (“MES”) – New system

Interfaces between the following software applications and recommend validation approach.

PLM to and from ERP

ERP to and from MES

ERP to and from LIMS

ERP to and from QMS

QMS to and from LIMS

MES to and from LIMS

MES to and from PLM

MES to and from OT Middleware

BarTender from:

SAP – Product Labels