Job Details: CSV Engineer


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
CSV Engineer


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



Similar Jobs

Amgen Jobs in Ireland

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



Similar Jobs

Amgen Jobs in Ireland

Jobs in Water

We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

Apply for this Job Offer
Name: (*) 
Email: (*) 
Phone: (*) 
Please Provide a Cover in the English Language.
CV: (*) 
Are you human ?
Share on your Facebook Page: