Validation Engineer
Validation Engineer - Exciting Opportunity in Carlow, Ireland
Job Type: Contract
Location: Carlow, Ireland
Industry: Pharmaceutical / Biotechnology / cGMP Regulatory Environment
Are you ready to take on a rewarding challenge in the dynamic pharmaceutical and biotechnology industry?
We are currently seeking a passionate and driven Validation Engineer to join a team committed to ensuring the highest standards of quality and compliance in a cGMP manufacturing environment. This is an excellent opportunity for professionals with experience in validation to enhance their career while working on cutting-edge technology in the heart of Ireland.
Key Responsibilities
As a Validation Engineer, you will play a key role in ensuring validation and qualification activities are performed to the highest standards. Your responsibilities will include, but are not limited to:
Design & Documentation: Author, review, approve, and execute qualification/validation documentation and cycle development studies, ensuring compliance with cGMP and regulatory standards.
Change Control Management: Oversee the development and execution of change controls, ensuring that any modifications meet the required standards and are validated appropriately.
Technical Troubleshooting: Resolve any technical issues that arise during the execution of validation studies, using root cause analysis to find and address system failures.
Collaboration: Work closely with cross-functional teams, including Production, Maintenance, and Quality, to ensure seamless execution of cycle development and performance qualification activities.
Compliance & Audits: Play an active role in maintaining compliance with global policies, GMP guidelines, and regulatory requirements, while supporting audits and inspections as required.
Continuous Improvement: Drive continuous improvement initiatives through Lean Six Sigma methodologies, contributing to the enhancement of processes and systems.
What You Will Need
To succeed in this role, you should possess a strong technical background and relevant experience in the pharmaceutical or biotechnology sectors. The ideal candidate will have:
Education: A relevant Level 8 technical qualification in Pharmaceutical, Biological, Chemical sciences, or Engineering.
Experience: A proven track record in validation and qualification within a GMP environment, with hands-on experience in a similar role.
Key Skills:
Extensive knowledge of equipment validation, process validation, and sterilisation technologies
Experience with CTU equipment qualification and thermal mapping
Strong technical troubleshooting abilities, especially in resolving deviations and exceptions
Familiarity with automation systems (e.g., DeltaV, Pi System) would be an advantage
Excellent proficiency in Microsoft Office and related software applications
Project management skills and the ability to lead technical projects
A solid understanding of regulatory requirements and GMP guidelines
Personal Attributes: Strong communication skills, with the ability to engage with cross-functional teams and external stakeholders. A collaborative mindset and ability to work both independently and within teams are essential.
Desirable Experience
In addition to the core qualifications, the following experience will be beneficial:
Sterile Fill-Finish processes and associated equipment
Filter Validation and Container Closure Integrity
Autoclave/SIP Sterilisation Validation
Isolator Qualification (Filling, Sterility, Material Transfer)
Temperature Mapping and Cleaning Validation
Project Management Certification
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 – https://www.hero.ie/
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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