Job Description

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.

We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.

The main purpose of the Validation Officer is to to prepare, plan, co-ordinate and execute all site validation activities.

General Duties:

• Development of User Requirement Specifications
• Development of Manufacturing Procedures
• Qualification and re-qualification of equipment and utilities
• Development and execution of System Impact Assessments and Component Impact Assessments
• Development and execution of Validation Risk Assessments and Design Reviews
• Development and execution of Design Qualifications, Installation Qualifications, Operational Qualifications and Performance Qualifications taking a System Lifecycle Approach
• Development and execution of Process Validation studies
• Validation of computerised systems validation
• Validation of Automated System
• Validation of sterilisation equipment and cycles
• Performance of Factory Acceptance Testing
• Control of delegated Validation Plans
• Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

• A Life Science or Chemical Engineering degree or equivalent
• 3-5 years of validation experience within the pharmaceutical manufacturing industry
• Knowledge of production processes
• Systems, product, industry and equipment knowledge
• Use of statistical techniques
• Knowledge of analytical, technical and engineering methods

Competency requirements are as follows:

• Attention to detail
• Time Management
• Planning skills; Problem solving
• Organizational skills; communication Skills
• Protocol and technical report writing skills and Computer literacy

Fresenius Kabi