Are you a CSV Engineer with Fill Finish experience in the biotech or pharma industries? Would you like to work for a multinational Biopharmaceutical company based in Waterford? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
CSV Engineer - Waterford
Employer
Our Client is one of the world's leading Biotech companies. Their Waterford plant is state-of-the-art facility for finishing of biopharmaceuticals and employs a high level of automation, including Manufacturing Execution Systems and was named one of Ireland?s top 10 best large workplaces by Great Place to Work Ireland.
Job Description
Our client currently seeks a CSV Engineer to join their team.
The CSV Engineer/Specialist will partner with project teams in performing Information Systems CSV.
12 Month contract/Permanent.
Development and execution of the qualification of Information Technologies (IT) Infrastructure (i.e., servers, networks and network components) following the GAMP IT Infrastructure Guide.
Development and execution of qualification & validation of Information Systems software (GAMP category 1, 2, 4 and 5) following GAMP5 guidance.
Development of life cycle documents necessary to address the validation lifecycle (Planning, Risk, Implementation, and maintenance of the validated state).
Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for equipment/systems.
Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
Ensure that appropriate Site Validation Listing is established and controlled.
Review/Approval of all Computer Systems/Software Validation Documentation.
Requirements:
A Bachelor?s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or three years relevant experience).
Experience with the management, development and/or validation of Information Systems Technology projects is preferred.
This experience may include but is not limited to the following: Windchill, TrackWise, Master Control, Agile PLM Software, Aegis, SharePoint, Oracle, SQL, Manufacturing Execution Systems, LIMS, LIS, software quality testing etc.
Prior experience in working with cGMPs and/or GLPs,and Quality Systems is preferred.
Experience working in the Pharmaceutical / Medical Device industry.
Have the ability to communicate IT/Validation concepts/strategies to project teams.
Be a self-starter and be motivated to provide a solid product quality and customer experience.
Be adaptable to a fast pace working environment
Be able to integrate and interact well within the customer environment.
Package:
Contract rate dependent on prior experience
Contract duration: 12 - 18 months
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
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Jobs in Water
Are you a CSV Engineer with Fill Finish experience in the biotech or pharma industries? Would you like to work for a multinational Biopharmaceutical company based in Waterford? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
CSV Engineer - Waterford
Employer
Our Client is one of the world's leading Biotech companies. Their Waterford plant is state-of-the-art facility for finishing of biopharmaceuticals and employs a high level of automation, including Manufacturing Execution Systems and was named one of Ireland?s top 10 best large workplaces by Great Place to Work Ireland.
Job Description
Our client currently seeks a CSV Engineer to join their team.
The CSV Engineer/Specialist will partner with project teams in performing Information Systems CSV.
12 Month contract/Permanent.
Development and execution of the qualification of Information Technologies (IT) Infrastructure (i.e., servers, networks and network components) following the GAMP IT Infrastructure Guide.
Development and execution of qualification & validation of Information Systems software (GAMP category 1, 2, 4 and 5) following GAMP5 guidance.
Development of life cycle documents necessary to address the validation lifecycle (Planning, Risk, Implementation, and maintenance of the validated state).
Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for equipment/systems.
Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
Ensure that appropriate Site Validation Listing is established and controlled.
Review/Approval of all Computer Systems/Software Validation Documentation.
Requirements:
A Bachelor?s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or three years relevant experience).
Experience with the management, development and/or validation of Information Systems Technology projects is preferred.
This experience may include but is not limited to the following: Windchill, TrackWise, Master Control, Agile PLM Software, Aegis, SharePoint, Oracle, SQL, Manufacturing Execution Systems, LIMS, LIS, software quality testing etc.
Prior experience in working with cGMPs and/or GLPs,and Quality Systems is preferred.
Experience working in the Pharmaceutical / Medical Device industry.
Have the ability to communicate IT/Validation concepts/strategies to project teams.
Be a self-starter and be motivated to provide a solid product quality and customer experience.
Be adaptable to a fast pace working environment
Be able to integrate and interact well within the customer environment.
Package:
Contract rate dependent on prior experience
Contract duration: 12 - 18 months
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
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Amgen Jobs in Ireland
Jobs in Water
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical