Back to Job SearchROLE OVERVIEW
We are currently looking for a Senior Validation Specialist to join a leading biopharmaceutical organization based in a dynamic and regulated industry. This is an exciting opportunity for a seasoned professional to oversee validation and qualification activities, ensuring compliance with cGMP, FDA, and European regulations while supporting quality assurance and operational excellence.
In this role, you will play a critical part in managing validation lifecycle documentation, reviewing and approving equipment, facility, and utility validation deliverables, and driving continuous improvement initiatives to enhance validation processes and standards.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Senior Validation Specialist will be varied; however, the key duties and responsibilities are as follows:
- Oversee validation and qualification deliverables, including URSs, validation plans, and qualification documentation (DQ, IQ, OQ, PQ), ensuring requirements traceability throughout the project life cycle.
- Review and approve validation lifecycle documents related to equipment, facilities, and utilities, ensuring compliance with cGMP and validation standards.
- Conduct periodic reviews of validated GxP equipment, facilities, and utilities, and perform validation impact assessments prior to implementing changes.
- Support production and technical teams in validation activities, manage deviations and CAPAs to maintain system integrity, and ensure deviations are well documented with corrective actions taken.
- As the Senior Validation Specialist, you will contribute to continuous improvement and standardization of validation practices.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Senior Validation Specialist, we are looking to identify the following on your profile and past history:
- A Degree or higher level in Engineering, Biology, Biomedical Science, Life Science, or a related discipline.
- Extensive experience (5–10 years) working within validated GxP environments, with a strong understanding of validation methodologies, quality systems, and industry regulations.
- Proven expertise in managing validation lifecycle activities, risk assessments, deviations, and change controls within a regulated manufacturing setting.
WHAT’S IN IT FOR YOU?
Joining our client offers an excellent platform to develop your expertise in validation within a leading life sciences organization. You will have the opportunity to work on impactful projects, contribute to compliance and process improvements, and be part of a forward-thinking team committed to quality and innovation.
Key Words: Validation/ Specialist/ GxP/ cGMP/ Equipment/ Facilities/ Utilities/ Regulatory/ Quality/ Compliance/ Risk Assessments/ Deviations/ CAPA/ Continuous Improvement/ Life Sciences/ Manufacturing
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
