Validation Engineer
1 week ago
Validation Engineer - Exciting Career Opportunity in Carlow, Ireland
Job Type: Contract
Location: Carlow, Ireland
Industry: Pharmaceutical / Biotechnology / cGMP Regulatory Environment
Are you eager to take on a rewarding challenge in the fast-paced pharmaceutical and biotechnology sectors?
We are seeking an experienced and motivated Validation Engineer to join our team, dedicated to upholding the highest standards of quality and compliance in a cGMP manufacturing environment. This is a fantastic opportunity for professionals with a background in validation to further their career while working with cutting-edge technology in the heart of Ireland.
Key Responsibilities
As a Validation Engineer, you will be responsible for ensuring validation and qualification activities meet the highest standards. Your key responsibilities will include:
- Design & Documentation: Develop, review, approve, and execute qualification/validation documentation and cycle development studies, ensuring adherence to cGMP and regulatory standards.
- Change Control Management: Oversee the creation and execution of change controls, ensuring all modifications meet required standards and undergo appropriate validation.
- Technical Troubleshooting: Troubleshoot and resolve technical issues encountered during validation studies, using root cause analysis to address system failures and deviations.
- Collaboration: Work closely with cross-functional teams (e.g., Production, Maintenance, Quality) to ensure smooth execution of cycle development and performance qualification activities.
- Compliance & Audits: Support global policy compliance, GMP guidelines, and regulatory requirements, participating in audits and inspections as necessary.
- Continuous Improvement: Drive process and system enhancements through Lean Six Sigma methodologies, fostering a culture of continuous improvement.
What You Will Need
To thrive in this role, you'll bring a strong technical background and relevant experience in the pharmaceutical or biotechnology industries. The ideal candidate will have:
- Education: A Level 8 qualification in Pharmaceutical, Biological, Chemical Sciences, or Engineering.
- Experience: Demonstrated experience in validation and qualification within a GMP environment, with hands-on expertise in a similar role.
Key Skills:
- Expertise in equipment validation, process validation, and sterilization technologies.
- Experience with CTU equipment qualification and thermal mapping.
- Strong technical troubleshooting skills, particularly in addressing deviations and exceptions.
- Familiarity with automation systems (e.g., DeltaV, Pi System) is a plus.
- Proficiency in Microsoft Office and related software tools.
- Project management experience, with the ability to lead technical projects.
- Strong understanding of regulatory requirements and GMP guidelines.
Personal Attributes:
- Excellent communication skills, with the ability to engage effectively with cross-functional teams and external stakeholders.
- A collaborative mindset and the ability to work independently and as part of a team.
Desirable Experience:
Additional experience in the following areas will be an advantage:
- Sterile Fill-Finish processes and related equipment
- Filter Validation and Container Closure Integrity
- Autoclave/SIP Sterilization Validation
- Isolator Qualification (Filling, Sterility, Material Transfer)
- Temperature Mapping and Cleaning Validation
- Project Management Certification
If you're ready to make a significant impact in a fast-paced, dynamic environment and advance your career in the pharmaceutical or biotechnology industry, we encourage you to apply today
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