Validation Specialist

4 months ago

Edinburgh, United Kingdom RoslinCT Full time

**Validation Specialist**

**Location**: Shawfair, Dalkeith

**Who are we?**

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here

**Why join us?**
- The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
- A generous salary package - we reward our people at the level they deserve.
- 31 days of annual leave, plus 4 public holidays which increases with tenure.
- A competitive company pension scheme to help you save for the future.
- Group Life Cover - you are automatically covered for three times your basic salary to give you and your family peace of mind.
- Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
- Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

**Your dream role**
- An exciting opportunity to join our high performing team as a **Validation Specialist.**:

- Responsible for the regulatory compliance of the facility and equipment validation activities and the preparation and execution of validation protocols and reports.
- You will also support GMP project management activities in the validation of a new cell therapy facility.
- Manage and perform routine qualification, calibration, and maintenance of equipment.
- Complete and review quality related documentation including but not limited to validation documents, change controls, deviations, and risk assessments in accordance with GMP and standard operating procedures.
- Ensure that the confidentiality of all information to clients and patients is always maintained.
- You may communicate procedures and results with clients.
- Plan and undertake the validation of new equipment and to advise and assist others in this.
- Comply with Health and Safety policies and procedures.
- Provide out of hours cover for critical equipment alarms as required on a rotational basis.
- Contribute to the set up and execution of the validation schedule for the new facility.
- Ensure the data integrity of software systems.

**About you**
- Experience with cleanroom facilities, manufacturing, and QC testing equipment would be advantageous.
- Demonstrable experience of working with a validation programme in a GMP environment.
- Experience in a sterile manufacturing facility strong preferred.
- Flexible and adaptable to react to rapid changes in project priorities.
- A working knowledge of UK laws and regulations for cell therapy products and tissue donation would be advantageous.
- Excellent communication and interpersonal skills, with the ability to build strong working relationships internally and externally
- Competent in the use of Microsoft Office products
- Exceptional organisational and planning skills with the ability to multi-task in a fast-paced environment
- Excellent attention to detail with a real desire to continually develop and improve our processes.

**Qualifications**

**Next Steps

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