Job Details: Senior Validation Engineers


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.
Senior Validation Engineers
Job Description




Contributing to the preparation and review of the Validation Master Plan

Managing the preparation, review and issuing of Validation Protocols and Reports

Generating Validation Documentation including Risk Assessments, Traceability Matrices, and Validation Reports.

Reviewing and Approving Specifications associated with Equipment, Processes, Products and Computerised Systems.

Implementation of Process Validation of new products

Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams

Establishing, implementing and directing validation and revalidation activities.

Liaising with contract manufacture customers in seeking their approval for protocols and reports where appropriate

Managing the validation requirements of company and third party suppliers and Contract Manufacturer Organisation’s.

Working directly with a cross functional team to define inputs and requirements to the MVP.

Reviewing and managing Change Control Forms for Validation/Compliance implications.

Conducting Routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.

Updating existing quality documentation related to validation activities.

Identifying training requirements in support of validation.

Conducting Risk Assessments.

 


Requirements:



Bachelor's degree in Science, Engineering, Technology or a related discipline.

5 years’ experience as a Validation Engineer in the Medical Devices or related Healthcare industry.

Experience of GxP Computerised Systems

Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.

Familiar with the GAMP5 Guidelines.

Excellent communication skills, including ability to advise and influence

Excellent understanding of validation concepts and documentation




Package:

€65k - €75k Basic salary 

Permanent Position

Company Benefits



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



Job Description




Contributing to the preparation and review of the Validation Master Plan

Managing the preparation, review and issuing of Validation Protocols and Reports

Generating Validation Documentation including Risk Assessments, Traceability Matrices, and Validation Reports.

Reviewing and Approving Specifications associated with Equipment, Processes, Products and Computerised Systems.

Implementation of Process Validation of new products

Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams

Establishing, implementing and directing validation and revalidation activities.

Liaising with contract manufacture customers in seeking their approval for protocols and reports where appropriate

Managing the validation requirements of company and third party suppliers and Contract Manufacturer Organisation’s.

Working directly with a cross functional team to define inputs and requirements to the MVP.

Reviewing and managing Change Control Forms for Validation/Compliance implications.

Conducting Routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.

Updating existing quality documentation related to validation activities.

Identifying training requirements in support of validation.

Conducting Risk Assessments.

 


Requirements:



Bachelor's degree in Science, Engineering, Technology or a related discipline.

5 years’ experience as a Validation Engineer in the Medical Devices or related Healthcare industry.

Experience of GxP Computerised Systems

Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.

Familiar with the GAMP5 Guidelines.

Excellent communication skills, including ability to advise and influence

Excellent understanding of validation concepts and documentation




Package:

€65k - €75k Basic salary 

Permanent Position

Company Benefits



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





We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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