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Validation Officer

  • Job
    Full-time
    Mid & Senior Level
  • Engineering
    Healthcare
  • Port Elizabeth

AI generated summary

  • You need a Life Science or Chemical Engineering degree, 3-5 years in pharma validation, production process knowledge, analytical skills, and strong communication, planning, and problem-solving abilities.
  • You will develop user requirements, execute qualifications, perform validation studies, assess risks, and conduct investigations while ensuring compliance throughout the system lifecycle.

Requirements

  • A Life Science or Chemical Engineering degree or equivalent.
  • 3-5 years of experience of validation in the pharmaceutical industry.
  • Knowledge of production processes
  • Systems, product, industry and equipment knowledge
  • Use of statistical techniques
  • Knowledge of analytical, technical and engineering methods
  • Attention to detail
  • Time Management
  • Planning skills; Problem solving
  • Organizational skills; communication Skills
  • Protocol and technical report writing skills and Computer literacy

Responsibilities

  • 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

FAQs

What is the main purpose of the Validation Officer position?

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

What qualifications are required for the Validation Officer role?

A Life Science or Chemical Engineering degree or equivalent is required.

How many years of experience in validation within the pharmaceutical industry are expected?

3-5 years of experience in validation in the pharmaceutical industry are expected.

What types of systems and equipment will I be validating in this position?

You will be validating computerized systems, automated systems, sterilization equipment and cycles, and performing Factory Acceptance Testing among other responsibilities.

What are some of the general duties of the Validation Officer?

General duties include developing User Requirement Specifications, manufacturing procedures, executing various qualifications, conducting validation studies, and controlling delegated Validation Plans.

What skills are essential for a Validation Officer?

Essential skills include attention to detail, time management, planning and problem-solving skills, organizational abilities, communication skills, protocol and technical report writing skills, and computer literacy.

Is knowledge of production processes important for this role?

Yes, knowledge of production processes is important for the Validation Officer role.

What tools or techniques will I be expected to use in this position?

You will be expected to use statistical techniques and tools like Kabitrack to perform investigations.

Are there opportunities for professional growth within the company?

Yes, Fresenius Kabi is committed to employee development and offers opportunities for professional growth.

What is the company’s dedication or purpose?

The company's dedication is "caring for life," which drives excellence in everything they do.

Manufacturing & Electronics
Industry
10,001+
Employees
1912
Founded Year

Mission & Purpose

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its “Vision 2026”, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.