Validation Engineer
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| Job Type | Contractor |
| Area | Westmeath, Ireland |
| Sector | EngineeringQualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2089 |
| Job Views | 599 |
- Description
- We have an opening for a contract Validation Engineer at our Clients drug product manufacturing & development facility in the Midlands. In this role you will be Validation SME responsible for execution of routine site validation activities (Re qualifications, cleaning validation, facility qualifications & validation risk assessments), with a provision for additional or specialist SME support on a project-dependent basis (e.g. GAMP, CSV, C&Q, EMPQ, etc.).
Why you should apply:
Join a company who put their patients first, and are committed to integrity and the pursuit of excellence at all times
This is an excellent opportunity to use your expertise to support and implement Validation strategies
What you will be doing:
Support Validation lead with Site Master Validation Plan revisions as required for changes in validation strategy.
Implementation and subsequent maintenance of site cleaning validation plan. Revision as required for new product additions.
SME for qualifications during site regulatory inspections or third-party audits.
Assessment of site systems for compliance with new or developing regulatory expectations as they apply to validation.
Validation SME on various site projects.
Process validation execution for new product introduction.
Execute assessments of validated state of 6 validated site systems, including reporting on qualification status of systems for annual reports such as APQR.
Drug formulation and associated equipment
Drug filling and packaging and associated equipment
Dispensing / containment / weighing
Clean utilities including Process air, PUW, CIP and gas supply system
Automation
HVAC system
Preparation of validation protocols for routine site activities:
Periodic qualification batches based on process changes (new suppliers, significant changes, etc.)
Qualification protocols for significant changes to process equipment and / or systems e.g. manufacturing train, utilities etc.
Project feasibility and/or baseline studies as required
Seasonal temperature mapping activities
Shipping validation
Training site personnel on execution of validation protocols and validation sampling.
Generation of validation summary reports summarising site qualification / validation activities and the validation status of the affected system(s).
Validation reviewer on site documentation as required, including but not limited to:
Annual Product Quality Review
Equipment Periodic reviews
Annual HVAC qualification report
Annual Environmental Monitoring report
Annual PUW performance report
Coordinating Equipment Periodic Review activities with Operations personnel
Routine review of deviations and change controls for assessment of impact to validated status of site processes / equipment / systems.
What you need to apply:
An individual with a minimum of 7 year’s validation experience on a range of pharmaceutical manufacturing sites and/or multiple validation projects.
knowledge of and experience with the application of the principles of the FDA’s guidance for industry for Process Validation.
Knowledge and experience with Cleaning Validation for a pharmaceutical manufacturing site.
Experience with interactions with Regulatory Inspectors as a validation SME.
Ability to keep current with latest / developing trends in regulatory expectations as they apply to validation.
Knowledge of Facility and utility qualification
Knowledge of use of statistical data to support process verification. Knowledge/use of mini-tab an advantage.
