Description
Validation EngineerThis global client is looking for a Validation Engineer to provide technical process support to the Sterile Integrated Process Team (IPT) in accordance to meeting the Priorities of: Compliance, Supply, Strategy and Profit Plan.
Key Responsibilities:
* Conduct validation activities in compliance with US and EU regulations.
* Develop and execute validation documentation as required (e.g. IQ, OQ, PQ plans, protocols
* Provide Technical expertise over a range of projects within the IPT, such as the introduction of new equipment and improvement to current manufacturing processes etc.
* Responsible for the preparation, review and approval of relevant technical documentation, risk assessments, CAPA`s etc.
* Co-ordination, implementation and active participation in the site validation program for processes, equipment, software, methods, utilities/facilities, cleaning and sterilisation.
* Ensure highest Quality & Compliance standards
Key Skills & Experience Required:
* Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Technical, Engineering, Manufacturing, Process, Quality etc.)
* Good proven experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical/Engineering/Process/Quality role in a manufacturing environment.
* Successful candidates should have technical and operational experience in one or more of following disciplines:
- Equipment Sterilisation/Decontamination (Steam, Dry Heat, VHP)
- Sterilising Filtration
- Aseptic Filling/ Visual Inspection
- Lyophilisation
- Technology Transfer/New Product Introduction for Steriles
- Cleaning Validation
* Demonstrated self-motivation/direction skills with a continuous improvement focus.
* Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams * Advanced PC skills such as Excel, Word, PowerPoint
* Demonstrated ability to prepare and execute Validation protocols
To apply for this fantastic opportunity please forward your CV today