Process CQV Engineer
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Contractor |
| Area | Louth, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2368 |
| Job Views | 103 |
- Description
- Team Horizon currently has an exciting opening for a Process CQV Engineer to support process tech transfers in Manufacturing.
What you will be doing:
Assist in site start up and project related activities (particularly CQV):
Support package owners on vendor management and equipment or process related activities and queries.
Generate equipment verification & validation protocols and reports as required.
Review vendor documentation for completeness and accuracy.
Participate in FAT and vendor related activities.
Participate in commissioning of process equipment and associated automation as needed. Support issue resolution in these areas as needed.
Support CQV execution team by participating in verification & validation related activities as required.
Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state.
Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit.
Participate in and/or lead facility fit assessments for new product introductions.
Implement equipment CAPA’s and performance improvements
Provide equipment technical support and troubleshooting.
Provide routine Automation support, troubleshooting and maintenance.
Support the implementation of Global Requirement Program tools and techniques within the Operation Unit. (for e.g. Operator Care, PdM, PMO, Work Management)
Support the use of PI to provide business efficiency.
Identify equipment and process improvement projects as needed.
Work with the portfolio management process to identify projects/support demands from the Core Units.
Champion and Support Energy saving programs/projects within the Operating Unit.
Write equipment assessments to support investigation closure.
Change Control write up and close out.
Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented.
Participate in cross-functional project teams as applicable
Support audit preparation.
Implement and support continuous improvements that reduce cycle times and operational costs.
Develop and maintain database for department tracking and data analysis needs, as applicable
Complete biennial review and PQS updates.
Support the disposition process. Ensure all data ready in timely fashion in support of OpU disposition metric.
Perform additional duties at the request of the direct manager.
Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Lead/Manufacturing Technology Lead.
Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
What you need to apply:
Excellent communication skills including computer literacy and ability to work independently and in team
Experience and knowledge of DeltaV (or equivalent) MCS platform preferred.
Familiarity with Bioreactor, Chromatography and Ultra filtration production operations is desirable.
Minimum of 5 years’ experience in a large-scale in a Biopharmaceutical/pharmaceutical facility.
Ideally, experience working in a Manufacturing Technology team in a ‘greenfield’ context of similar size and scale.
