Validation Engineer Contractor
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Job Type | Contractor |
Area | Longford |
Sector | EngineeringQuality |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | #2205 |
Job Views | 243 |
- Description
- We have an exciting opening on our client’s manufacturing facility in the midlands for an experienced Validation Engineer.In this role, you will be responsible for ensuring all aspects of activity within the Process Support group adhere to required policies and procedures, including safety and training while meeting its customer quality, service, regulatory, financial and safety goals
You will provide necessary support to the product manufacturing/testing team, ensuring that project timelines, quality and production targets are attained.
Why you should apply:
Experience a culture driven by driven by diversity and innovation
Opportunity to work as a Subject Matter Expertise and take lead in validation activities pertaining to the project.
What you will bedoing:
Assist in process/product development/improvement projects, in compliance with the applicable requirements.
Be a Subject Matter Expertise and take lead in validation activities pertaining to the project.
Be involved in all Validation Cross Functional Teams (CFT’s) at the site to ensure adherence to required policies and procedures, including safety and training.
Assist in preparation and execution of validation protocols.
Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
Liaise with Engineering and external vendors regarding equipment User Requirement Specifications
Lead validation aspects of Facility, Utility, Equipment qualifications
Conduct Test Method Validation.
Lead software validation and 21CFR Part 11 assessments
To direct and support investigations, utilizing investigation tools, to ensure a systematic and logical approach is applied to achieve root cause resolution
Take lead to develop and maintain working relationships with cross-functional peers, including Technical Support, Quality and Supply Chain.
Champion the principles and practices of GMP/GLP. Ensure all personnel entering the lab area adhere to the high standards of GMP/GLP.
Ensure effective communication of process information and manufacturing issues to Team Leader.
To ensure that the plant meets the quality requirements of its customers, internal quality systems, internal & external auditors and other external agencies.
To liaise with, seek appropriate advice from and report when necessary to colleagues where required
What you need to apply:
A third level qualification in Chemistry or related Science, preferably a Bachelor’s Degree
A relevant third level qualification combined with background and experience as this provides a strong foundation for this job function
Ability to be responsible for the day-to-day running of your workload and projects to meet the timelines set out.
Ability to take responsibility for improvement / development / projects and technical decisions related to product performance and quality.