Senior Validation Engineer
CR/078168
Posted: 25/06/2025
- Competitive
- Ireland, County Carlow, Carlow
- Contract
Orion Group Life Sciences are currently recruiting a Senior Validation Engineer on behalf of our Multinational Biopharmaceutical Client based in Carlow on an 11-month contract with potential to extend.
Hybrid Role
Role Description
An exciting opportunity is available for a Senior Engineering Specialist (Validation) within a cGMP regulatory environment. The successful candidate will support Cleaning Validation activities, including Recovery and Cleanability studies.
Role Functions
(Functions include, but are not limited to, the following)
What you will do:
Bring energy, knowledge, and innovation to carry out the following:
Experience, Knowledge & Skills
What skills you will need:
To excel in this role, the following experience and capabilities are typically required:
Additional knowledge and experience in the following areas is advantageous:
Qualifications & Education
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Hybrid Role
Role Description
An exciting opportunity is available for a Senior Engineering Specialist (Validation) within a cGMP regulatory environment. The successful candidate will support Cleaning Validation activities, including Recovery and Cleanability studies.
Role Functions
(Functions include, but are not limited to, the following)
What you will do:
Bring energy, knowledge, and innovation to carry out the following:
- Design/Author/Review/Approve/Execute qualification and validation documentation and cycle development studies in line with the standard approval process.
- Design/Author/Review/Approve/Execute development and execution of change controls.
- Resolve technical issues encountered during study execution.
- Engage with Production, Maintenance, and Quality representatives during execution of Cycle Development and Performance Qualification activities.
- Provide technical input into quality notifications by authoring/reviewing/approving investigations.
- Perform root cause analysis of system failures or substandard performance using standard tools and methods to resolve equipment and system issues.
- Support continuous improvement initiatives through Lean Six Sigma methodologies.
- Serve as a validation representative for cross-functional projects and represent the validation function in global technical forums.
- Drive compliance with Global Policies, Procedures, Guidelines, and regulatory requirements; execute current Good Manufacturing Practices (cGMP) in all job functions, ensuring awareness of impact on GMP and compliance.
- Maintain accountability for compliance through documentation, risk assessments, corrective actions, audit and inspection participation, and proactive compliance issue resolution.
- Support regulatory audits and submissions as required.
- Contribute to a culture focused on safety and compliance.
- Perform additional duties as assigned.
Experience, Knowledge & Skills
What skills you will need:
To excel in this role, the following experience and capabilities are typically required:
- Experience in cleaning validation, including CD and PQ of mobile vessels (CIP) and parts washers (COP), recipe development and optimization, cleaning verification, cleanability and recovery studies using TOC, ICP, and swab methods, determination of acceptable residual limits, worst-case soil matrices, and strategy development.
- Significant experience in a similar role within a GMP manufacturing environment, demonstrating individual contribution to business outcomes.
- Relevant technical qualification(s) in Applied Pharmaceutical, Biological, Chemical Sciences, or an Applied Technical/Engineering discipline.
- Experience in Exception/Deviation Management and Change Control.
- Demonstrated ability to lead technical projects.
- Familiarity with process monitoring systems, automation systems (e.g., DeltaV), operational intelligence and data systems (e.g., Pi System) within a GMP environment is desirable.
- Evidence of continuous professional development is preferred.
- Knowledge of relevant regulatory requirements and standards (Irish, European, and International).
- Strong analytical skills, with the ability to interpret complex data and link findings to equipment performance and investigation outcomes.
- Proficiency in writing reports, standards, and policies.
- Experience in equipment and process validation.
- Familiarity with Sterile Fill-Finish processes and equipment.
- Proficiency in Microsoft Office and job-related applications.
- Excellent communication, presentation, and interpersonal skills to work effectively with internal teams and external stakeholders.
Additional knowledge and experience in the following areas is advantageous:
- Filter Validation
- Container Closure Integrity (CCI) Qualification
- Shipping Qualification
- Periodic Equipment Validation
- Equipment Validation Lifecycle
- Project Management (experience or qualification)
- Autoclave/SIP Sterilization Validation
- Dry Heat Sterilization
- Isolator VHP/HVAC Qualification
- Controlled Temperature Units/Equipment Qualification
- Vial and Syringe Processing Technologies
Qualifications & Education
- Relevant technical qualification(s) in Applied Pharmaceutical, Biological, or Chemical Sciences, or in an Applied Technical/Engineering field.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Aoibhinn Daly
Recruitment Consultant
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