Validation SME (IRE)
Ellab is a leading global provider of temperature mapping, validation, calibration and monitoring solutions for critical processes in the life sciences, healthcare, and food industries. Our cutting-edge instruments and services ensure compliance with regulatory standards, safeguard product integrity, and optimize operational efficiency.
Position: Validation SME
Location: Bandon, Cork
Job Type: Full-time
Reports To: Service Manager
Job Purpose: Validation engineers plan, create, and execute tests that ensure a company’s manufacturing equipment produces products that meet performance, Are you a passionate validation engineer or specialist with 8 years of experience looking to take your career to the next level? At Ellab Ireland, we have the perfect opportunity for you as a Validation SME.
As a Validation SME, you will provide expert guidance and leadership for all validation activities within our pharmaceutical client sites. You will develop, review, and execute validation protocols to ensure our systems, processes, and equipment meet stringent regulatory standards. This role requires extensive experience in pharmaceutical validation, a deep understanding of industry regulations, and the ability to lead and mentor teams effectively. Additionally, you will mentor and train staff, fostering a culture of excellence and compliance.
You will be required to liaise directly with our clients, coordinate onsite activities, review & approve reports, resolve deviations and non-conformances, & promote the Ellab brand within Ireland.
We are seeking a highly experienced and knowledgeable Validation Subject Matter Expert (SME) to join our team.
Job Responsibilities:
Expert Guidance and Leadership:
- This is a technical role & requires an individual with troubleshooting capabilities as we as providing guidance and mentoring for our staff
- Set up and oversee jobs throughout the country.
- Provide strategic guidance on validation methodologies, protocols, and best practices to ensure compliance and operational efficiency.
Thermal Mapping:
- Provide training and mentorship to validation team members and other staff on validation procedures and regulatory requirements with emphasis on Thermal Mapping related activities.
- Foster a culture of continuous improvement, knowledge sharing, and adherence to best practices within the team.
- Oversee our thermal validation activities onsite.
- Execute validation activities – CTUS, autoclaves, steam quality testing, SIP, de-pyrogenation, tunnels & ovens, & monitoring equipment
Development and Execution of Validation Protocols:
- Lead the development, review, and execution of validation protocols (IQ, OQ, PQ) for pharmaceutical systems, processes, and equipment.
- Ensure all validation activities comply with FDA, EMA, GMP, and other relevant regulatory requirements.
Regulatory Compliance and Risk Management:
- Stay current with industry regulations and guidelines to ensure company practices remain compliant.
- Conduct comprehensive risk assessments and develop mitigation strategies to address potential validation issues.
Documentation and Quality Assurance:
- Oversee the preparation and maintenance of detailed validation documentation, including validation plans, protocols, reports, and SOPs.
- Review and approve validation documentation to maintain high standards of accuracy and regulatory compliance.
- Prepare and present validation reports to internal stakeholders and regulatory authorities as needed
Continuous Improvement:
- Identify opportunities for process improvements and lead initiatives to enhance validation practices.
- Implement innovative solutions to optimize validation efficiency and effectiveness.
Skills & Knowledge:
- Minimum of Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
- Minimum 8 years’ experience as a validation engineer / specialist in the pharmaceutical and regulated environment.
- Previous Validation / thermal mapping experience is essential for this role.
- Fluent spoken and written English is a must.
- Detailed knowledge of GMP.
- Be able to work on your own initiative.
- Attention to detail with a common-sense approach to problem solving.
- Extensive experience in developing and executing validation protocols and ensuring regulatory compliance.
Benefits:
- The opportunity to join a dynamic and rapidly growing company on a steep growth curve.
- A supportive and collaborative work environment where you can make a real impact.
- Market Leading salary and benefits package.
- Opportunities for professional development and growth.
- 21 Days Annual Leave
- Company Pension – Employer matches 5%
- Employee Assistance Programme.
- Income Protection Benefit.
- Death in Service Benefit.
To apply for this role please complete the form below attaching your CV and cover letter.
