New Opportunity for Senior Validation Engineers in Carlow!
We are seeking a highly skilled and motivated Senior Validation Engineer to join our clients team at their Carlow site! This exciting opportunity is perfect for individuals who thrive in a cGMP regulatory environment and are passionate about supporting the validation processes within pharmaceutical, biologics, and small molecule drug production.
The Senior Validation Engineer will play a pivotal role in supporting cleaning validation, including recovery and cleanability studies, while ensuring compliance with global policies, procedures, and regulatory requirements.
KEY RESPONSIBILITIES
* Design, Author, and Execute Validation Documentation: Lead the creation, review, and approval of qualification and validation protocols, including cycle development studies, in line with standard approval processes.
* Change Control Management: Author, review, and approve change controls, ensuring all changes are executed and documented according to cGMP guidelines.
* Technical Issue Resolution: Actively resolve technical issues encountered during validation study execution by applying a strong problem-solving approach and utilising standard tools and methods.
* Cross-Functional Collaboration: Engage with representatives from Production, Maintenance, and Quality during cycle development and performance qualification activities, ensuring smooth execution and alignment with project goals.
* Root Cause Analysis: Perform root cause analysis for system failures or substandard performance, addressing machine or system issues as necessary.
* Continuous Improvement: Support and promote continuous improvement initiatives using Lean Six Sigma methodologies to optimise processes and drive efficiency.
* Regulatory Compliance: Ensure full compliance with cGMP regulations, completing documentation, performing risk assessments, and closing out corrective actions. Participate in audits and inspections to maintain high standards of regulatory compliance.
* Representation and Technical Input: Serve as a validation representative in cross-functional projects and provide technical input during global technical forums.
* Audit and Inspection Support: Contribute to regulatory audits and submissions, providing detailed documentation and responding to inquiries as required.
* Safety and Compliance Culture: Work collaboratively with teams to drive a safe and compliant culture within the Carlow site.
KEY REQUIREMENTS
* Experience in Cleaning Validation: Proven experience in cleaning validation, including CD & PQ of mobile vessels (CIP) and parts washers (COP), with expertise in recipe development, optimisation, cleanability and recovery studies, and using techniques such as TOC, ICP, and swab methods.
* Experience in GMP Manufacturing: Significant experience in a comparable role within a GMP manufacturing environment, with a strong focus on validation and qualification activities.
* Technical Qualifications: A relevant technical qualification in Applied Pharmaceutical, Biological, Chemical Sciences, or a related Engineering field.
* Deviation Management & Change Control: Solid experience with deviation management, root cause analysis, and change control processes.
* Project Leadership: Demonstrated experience in leading technical projects related to validation and process improvements.
* Knowledge of Process Monitoring and Automation Systems: Familiarity with process monitoring systems (e.g., DeltaV) and operational intelligence/data systems (e.g., Pi System) is desirable.
* Regulatory Knowledge: Strong knowledge of Irish, European, and International regulatory codes, standards, and practices, with the ability to interpret and apply these requirements effectively.
* Strong Analytical Skills: Ability to analyse complex data and link it to equipment performance or out-of-specification findings.
* Excellent Communication Skills: Proficient in writing reports, standards, and policies. Strong interpersonal, communication, and presentation skills are essential to interface effectively with colleagues and external customers.
* Continuous Professional Development: Evidence of continuous professional development is desirable, demonstrating a commitment to learning and growing in the field.
* Technical Expertise in Sterile Fill-Finish: Experience in sterile fill-finish processes and related equipment is highly advantageous.
* Additional Knowledge: Experience with autoclave/SIP sterilisation validation, dry heat sterilisation, isolator VHP/HVAC qualification, controlled temperature units/equipment qualification, and vial and syringe processing technologies will be considered advantageous.
ADDITIONAL REQUIREMENTS
* Proficiency in Microsoft Office and other relevant job-related software applications.
* Ability to work in a team-oriented environment and foster collaboration with internal and external stakeholders.
* Flexibility to perform additional duties as assigned, contributing to the success of the validation team and broader organizational goals.
Ready to make an impact? Join our team and help drive excellence in equipment reliability and performance. Apply today and be part of our innovative journey!
Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.
For further information on this role please contact Róisín Vaughan on 086 440 3742 / consult@hero.ie.
Check out all our open jobs on our HERO Recruitment website - HERO Recruitment: Leading STEM Recruitment Agency.
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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