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Validation Engineer Job
Date: Sep 1, 2010
Location: Ireland
Validation Engineer-PRO007700
Description
Merck Sharp & Dohme - where patients come first
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.
Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.
Medicines discovered and developed by Merck scientists save and improve countless lives around the globe. Thanks to the people behind its life-enhancing discoveries, the Company ranks among the world's most innovative institutions in the medical sciences.
Merck Sharp & Dohme Biologics (Ireland) Ltd. is a subsidiary of Merck & Co. Inc., New Jersey, USA, one of the leading healthcare companies in the world. The company is investing €200 million in a new strategic vaccine facility in Carlow town. The project will support Merck's expanding global business in human vaccines and biologics and will create 170 new jobs by 2011.
This role is one our exciting job opportunities right now:
Validation Engineer
This role will be part of the Technical Services team starting up, validating and providing on going technical support to the filling processes at our Vaccines Formulation / Fill facility in Carlow
Key Responsibilities
* To co-ordinate and execute utility/equipment Performance Qualifications associated with a sterile Formulation/Fill facility.
* To actively participate in heat penetration/distribution studies associated with cycle development and PQ using Kaye thermal system and biological challenges.
* Participation in the drafting and reviewing of validation documentation and procedures.
* Accountable for the execution, completion and tracking of validation documentation to a required standard.
* Actively contribute to project teams.
* Partake in cleaning validation and process validation studies.
* Audit preparation and representation of the Technical Services department during regulatory body inspections as required.
Key Experience:
* Validation experience in vaccine or sterile product manufacturing would be an advantage (min 3 - 5 years)
* Thermal mapping experience using Kaye systems
* Experience in IMB/FDA environment advantageous.
* Strong technical writing and communication skills
* Must be flexible and able to manage multiple priorities.
* Must be goal-oriented and able to manage risks.
* Project management skills
Qualifications
Education:
* Degree level qualification in Science or Engineering.
Primary Location
:Ireland
Employee Status
:Regular
Number of Openings
:1
Description
Merck Sharp & Dohme - where patients come first
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.
Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.
Medicines discovered and developed by Merck scientists save and improve countless lives around the globe. Thanks to the people behind its life-enhancing discoveries, the Company ranks among the world's most innovative institutions in the medical sciences.
Merck Sharp & Dohme Biologics (Ireland) Ltd. is a subsidiary of Merck & Co. Inc., New Jersey, USA, one of the leading healthcare companies in the world. The company is investing €200 million in a new strategic vaccine facility in Carlow town. The project will support Merck's expanding global business in human vaccines and biologics and will create 170 new jobs by 2011.
This role is one our exciting job opportunities right now:
Validation Engineer
This role will be part of the Technical Services team starting up, validating and providing on going technical support to the filling processes at our Vaccines Formulation / Fill facility in Carlow
Key Responsibilities
* To co-ordinate and execute utility/equipment Performance Qualifications associated with a sterile Formulation/Fill facility.
* To actively participate in heat penetration/distribution studies associated with cycle development and PQ using Kaye thermal system and biological challenges.
* Participation in the drafting and reviewing of validation documentation and procedures.
* Accountable for the execution, completion and tracking of validation documentation to a required standard.
* Actively contribute to project teams.
* Partake in cleaning validation and process validation studies.
* Audit preparation and representation of the Technical Services department during regulatory body inspections as required.
Key Experience:
* Validation experience in vaccine or sterile product manufacturing would be an advantage (min 3 - 5 years)
* Thermal mapping experience using Kaye systems
* Experience in IMB/FDA environment advantageous.
* Strong technical writing and communication skills
* Must be flexible and able to manage multiple priorities.
* Must be goal-oriented and able to manage risks.
* Project management skills
Qualifications
Education:
* Degree level qualification in Science or Engineering.
Primary Location
:Ireland
Employee Status
:Regular
Number of Openings
:1
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