Job Details:
Role Description
Provide process/equipment engineering support in the area of sterilization science and technology to the ongoing requirements of the Parenterals Operating Unit. The process/equipment engineer is responsible for providing engineering and equipment qualification support to the operating unit ensuring that the equipment is safe, available, efficient and that all issues are resolved to support the manufacture and timely disposition of product.
This role focuses on maintaining the validated state of our sterilization processes, leading and resolving technical issues within the Operations Unit, implementation of CAPAs and process/equipment improvements, supporting the Engineering Technician population in the provision of routine technical support and trouble-shooting and supporting investigations for equipment and process related issues.
The Process/Equipment Engineer may also be responsible for project management and execution of assigned projects (short duration), which includes the management of internal company resources (assets financial and personnel), external engineering and vendors as part of the execution of projects. The direct management responsibility includes all support activities and functions necessary to ensure successful completion of project objectives.
The Process/Equipment Engineer is responsible for providing technical expertise during audits and also to present/defend engineering systems, applicable change controls, investigations and equipment qualification packages to the regulatory agencies if required.
Responsibilities
* Maintain the validated status of the equipment in the Parenterals facility by coordinating, planning, executing and reporting on the requalification schedule.
* Generate and execute documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, risk assessments, protocols and reports to maintain the equipment in a validated state.
* Ensure all equipment installed is safe, effective and in compliance with industry standards.
* Ensure all company and site engineering policies and procedures are adhered to.
* Provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs.
* Support investigations to providing appropriate root cause analysis, product/process impact assessments and effective CAPA implementation.
* Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues.
* Provide technical training on process and equipment as required by Operations.
* Develop and maintain productive links with process equipment & technology supplier and vendors.
* Identify process and equipment improvements and develop these into project scopes for this may also include progressing to funding approvals.
* Use of Manufacturing Intelligence (MI) for the development and maintenance of equipment and process related Key Performance Indicators.
* Support the development and implementation of GRP tools within the operating unit.
* Provide technical expertise during audits and also to present/defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies if required...
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