Validation Engineer

Description:

Job Description Packaging and inspection Validation Engineer
As a packaging and inspection validation engineer, you will be responsible for ensuring that all validation activities associated with the vial and syringe manufacturing facility are in compliance with division quality system requirements and recognised international standards.

Major Responsibilities:
* Development of the packaging and inspection validation strategy, validation plans, protocols and reports for all equipment and processes, not limited to FATs/SATs, IV/FTs, risk assessments, IOQ's, PQ's etc.
* Ensure all aspects of packaging and inspection validation adhere to required policies and procedures, including safety and training.
* Ensure that the site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. Knowledge of ISO 13485.
* Author and execute protocols, reports and assessments from a quality system documentation perspective for primary and secondary packaging, semi-automatic and automatic vision inspection machines and inline/offline leak tester devices used to support sterile vial and syringe Manufacturing.
* Update and maintain responsible Standard Operating Procedures (SOP's) in accordance with site and corporate requirements
* Prioritize workload in line with site priorities
* Participate as required in project activities.
* Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. Cross functional investigation team.
* Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations. Input to site validation guidance documents.
* Collate and report on relevant validation data/matrices.
* Assist in deviation and exception resolution and root cause analysis.
* Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area
* Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen's requirements, policies and procedures
* Attend and contribute to staff meetings and attend appropriate training sessions, as required

Experience/Background:
* A third level qualification in Science, Engineering or a relevant Quality discipline.
* Automated Inspection and/or Packaging experience in Pharmaceutical or Medical Devices
* Equipment commissioning experience an advantage along with Validation lifecycle documentation
* Problem solving ability and excellent oral and written communications skills
* Experience with introduction of New Products (NPI's)
* Minimum 4-6 years experience in a similar role.


Key Competencies:
* Customer service
* Honesty and consistency
* Planning and prioritisation
* Drive for results
* Creative and analytical thinking
* Focus on quality
* Attention to detail