Validation Engineer

Job Description

Our Carlow site is excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will support several aspects of Validation predominantly in one or more of the following areas: Isolator Sterilisation Controlled Temperature Units Cleaning Validation & Cleaning Recovery studies Filter Validation CCI & Shipping Qualification.

Bring energy knowledge innovation to carry out the following:

• Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.

• Design/Author/Review/Approve/Execute Execution/development of change controls.

• Resolving technical issues encountered during study execution.

• Engagement with Production Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.

• Technical input into quality notification by authoring/reviewing/approving investigations.

• Perform root cause analysis of system failures substandard performance using standard tools and methods to resolve machine and system issues.

• Support continuous improvement through Lean Six Sigma methodologies.

• Serve as validation representative for cross functional projects and represent the validation team at global technical forums

• Drive compliance of Global Policies Procedures and Guidelines regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions ensuring consideration of the impact on GMP and compliance and decisions made.

• Accountable for compliance via documentation completion risk assessments closing out corrective actions participation in audits and inspections and proactively highlighting any issues around compliance

• Supporting regulatory audits and submissions as required.

• Work collaboratively to drive a safe and compliant culture in Carlow.

• May be required to perform other duties as assigned.

What skills you will need:

In order to excel in this role you will more than likely have considerable experience in a comparable role with experience operating as individual contributor adding value to the business in a GMP manufacturing setting as well as the following qualifications/skills:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification the successful candidate will also have a proven track record in delivering excellence.

• Exception / Deviation Management and Change Control.

• Demonstratable experience of leading technical related projects.

• Knowledge of process monitoring systems automation systems (DeltaV) operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable

• Evidence of continuous professional development is desirable.

• Knowledge of regulatory/code requirements to Irish European and International Codes Standards and Practices.

• Ability to analyse and interpret complex data and link to equipment performance and out of specification findings as appropriate.

• Report standards policy writing skills required.

• Equipment and process validation.

• Sterile Fill-Finish processes and equipment.

• Proficiency in Microsoft Office and job-related computer applications required

• Excellent communication presentation and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

And Experience in one or more of the following validation disciplines:

• Validation of Tank CIP & Parts Washers for in-process components.

• Cleaning recovery studies using TOC and swab methods.

• CCI qualification.

• Shipping Qualification.

• Autoclave/SIP Sterilisation Validation.

• Dry Heat Sterilisation.

• Isolator AVS/VHP/HVAC Qualification.

• Controlled Temperature Units/Equipment Qualification.

Knowledge and experience of the below areas will be considered advantageous

• Equipment Periodic Validation

• Equipment Validation Lifecycle

• Project Management Skills/Qualification

• Vial and Syringe Processing Technologies

The successful candidate will be required to work both independently and in a cross-functional team to accomplish validation project objectives. Works with moderate work direction and is skilled and knowledgeable to the position.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines biologics and small molecule drug its initial launch the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

As an equal opportunity employer we are proud to be a company that embraces the value of bringing diverse talented and committed people together. Please dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

Required Skills:

Preferred Skills:

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