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Job Details

Validation Process Engineer

Company: Optimus Search Limited
Location: Cork
Reference: BBBH10055
Closing Date: 29 Mar 18
Type: Contract
Salary (£): Negotiable

Job Summary:

Are you a Validation Process Engineer interested in working for one of the world leading names in High-Tech Pharmaceutical Equipment Engineering?Are you looking for something new?!Then stop what you are doing and read on!


Are you a Validation Process Engineer interested in working for one of the world leading names in High-Tech Pharmaceutical Equipment Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!

Title: Validation Process Engineer

Rate: Negotiable

Location: Cork - Ireland

Type: Contract (12-18 Months)

A Fantastic new role has just opened up at one of our leading Cork based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

The proposed start date is January 2018 - We need YOU

Responsibilities include:

* To support all validation actively, developing and refining equipment and systems.
* Support the Department in maintaining a validated process and validated equipment.
* The support includes managing process improvement projects, problem solving for manufacturing issues, and support of key site processes.
* Ensuring the site Validation Master Plan is updated and completed annually.
* Ensuring the Process Plan is updated and completed annually.
* Carryout the Site Periodic Review, which involves ensuring that each department reviews their system and reports on the quality and validation status of their system.
* Carryout validation and annual qualification on the following types of equipment;

* WFI (Water for Injection), Compress Air, HVAC (Heating Ventilation & Air Conditioning) and Cleanroom classifications, LAF (Laminar Air Flow) and Smoke Studies, Vial Washers, Filling Machines, Cleaning validation on Process Vessels, Product Transfer Lines & parts, Warehouse Thermal Mapping, Production/Packaging processes

* Trending of quality metrics to identify area of improvement.
* Ensuring all engineering systems operate as per validated process and ensuring all routine validation is completed on time.
* Write and execute all validation life cycle documentation all the way through from requirement specifications to test documentation to validation reports.
* Implementation of a risk based approach to validation ensuring compliance of system.
* Computer System Validation and ensuring 21CFR11 compliance.
* Identify opportunities to implement process improvements and lean practices in all parts of the plant including Business Unit (Production and Packaging), Utilities, and Warehouse.
* On-going systems development in terms of Safety, Quality, Productivity, Output, Cost, and Yield.


* Engineering or Science Honours Degree.
* At least 5 years’ experience in validation within a GMP approved pharmaceutical or process industry with specific experience in batch preparation, filling environments, and clean utilities.
* Good knowledge of and experience with Process Validation, Technical Documentation, Engineering Standards, and Guidelines.
* Experience in working in a GMP regulated environment.
* Good knowledge of Eudralex, European Pharmacopeia, GAMP5, FDA standards, Computer System Validation, and current validation regulatory requirements.
* Excellent written and oral communications skills and the ability to deal with a variety of people on a wide range of tasks.
* Must be good record keeper and results analyser.

If you are interested please do not hesitate to email or call me!

+44 20 30969 392

Apply for this job: Validation Process Engineer

Contact Information:

Address:  Head Office
171-177 Great Portland Street, London
Tel:  +44 (0) 20 3418 8033
Fax:  +44 (0) 20 7287 4908
Website:  Visit Our Web Site

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