Senior Validation Engineer

RT Lane Recruitment
R.T. Lane Recruitment are currently recruiting for a Senior Validation Engineer to work with a Pharmaceutical Company in Carlow.
This is an 12-month contract with strong potential for extension.
**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. **
The successful candidate will be 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.
Within the role you will be acting as a technical SME & Senior CQ/ Validation Engineer reporting within Technical Engineering at Tier 1 and Tier 2 level as required.
The role will include –
- Work within a team of Validation professionals from ‘Intern’ level to Associate Director to own and execute the Validation & PQ aspects of the project.
- Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
- Act as SME on the process & equipment within the assigned area.
- Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area.
- Coordination of engineering sub-teams in the assigned area during execution of Cycle Development & Validation activities.
- Owning Change Management process for Equipment introduction within the assigned area for qualification / validation up to PQ stage.
- Effective application of LeanSixSigma and Change Management tools in the Validation group by:
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
- Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
To be considered for this position you must have the following:
- Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry.
- Minimum 2 years process equipment C&Q/ QA/ Validation experience on 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.
- Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
- 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
To apply for this job email your details to michelle@rtlanerecruitment.ie.