Job Details: Validation 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.
Validation Engineer
Job Description

Senior Process Validation Engineer
As a senior Process validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Process Validation Activities and Aseptic Process Simulations at the Sterile Manufacturing Site are in compliance with Division Quality System requirements and recognised international standards.

• Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial and Syringe Filling.
• Leading the team to ensure all aspects of activity within the Validation group adhere to required policies and procedures, including safety and training.
• Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• Generate protocols and reports.
• Pre-approve and post-approve validation support protocols and assessments from a quality system documentation perspective.
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
• Collate and report on relevant Validation data/matrices.
• Assist in deviation and exception resolution and root cause analysis.
• Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
• Participate as required in project activities.
• Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.


Requirements:
Job Description

Senior Process Validation Engineer
As a senior Process validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Process Validation Activities and Aseptic Process Simulations at the Sterile Manufacturing Site are in compliance with Division Quality System requirements and recognised international standards.

• Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial and Syringe Filling.
• Leading the team to ensure all aspects of activity within the Validation group adhere to required policies and procedures, including safety and training.
• Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• Generate protocols and reports.
• Pre-approve and post-approve validation support protocols and assessments from a quality system documentation perspective.
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
• Collate and report on relevant Validation data/matrices.
• Assist in deviation and exception resolution and root cause analysis.
• Develop and rollout Validation Training for the site on subjects assigned by the Site Validation Leader.
• Participate as required in project activities.
• Ensure all relevant employees are aware of corporate and relevant International Standards and their implementation throughout the plant.


Requirements:


We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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