R.T. Lane Recruitment are currently recruiting for a Validation Engineer to work with a Pharmaceutical Company in Carlow.
This is a 12-month contract with potential extension past this time period.
Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland.
Please note due to a high volume of applicants you will only be contacted if suitable for the position.
Brief outline of Role:
1. Primary responsibilities for the Validation Engineer include the following:
2. Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation).
3. Authoring project validation master plans; SOP and documentation updates.
4. Authoring validation protocols and final reports, executing validation studies, analysis of validation data.
5. Resolving technical issues encountered during study execution.
6. The successful candidate will be required to work in a cross-functional team and independently to accomplish validation project objectives.
7. Minimal work direction needed, highly skilled and knowledgeable to the position.
Roles and Responsibilities:
The role will require the leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas.
* Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.
* Cleaning Validation in Biotech facility & Cleaning Processes.
* Sterilisation – Autoclave & Load Qualification.
* Single Use Technologies – SUT and SU components/ manifolds.
* Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation.
* Ancillary Equipment for Bio-processing – Tube Welders/ Sealers/ Filter Integrity / Glove Integrity Testing.
* Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
* Parenteral Product Visual Inspection (Automated Inspection).
* High Potency and ICH Q5 products & containment methodologies.
The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience.
Experience, Knowledge & Skills:
* Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry.
* Minimum 2 years process equipment C&Q/QA/Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.
* Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach.
* SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection.
* Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
* Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.
* Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
Qualifications & Education:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences, Computer Sciences or applied Technical / Engineering qualification.
* The successful candidate will also have a proven track record in delivering excellence.
For more information or a full Job Description please contact – Michelle Power, R.T. Lane Recruitment on 022 46969, 087 032 8195 or email michelle@rtlanerecruitment.ie.
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