Eve Hegarty at Hyper Recruitment Solutions is currently supporting a key client in their search for a Validation Specialist. Securing this role will see you join a growing and well respected biotechnology company based in the Edinburgh area.
The main function of the Validation Specialist is to plan, organise and monitor the execution of the facilities and equipment maintenance, service, calibration and validation activities, to GMP standards. You will also take responsibility for the regulatory compliance of the equipment validation activities and the preparation and execution of validation protocols. In addition, you will support GMP project management activities in the validation of a new facility.
Key Words: Validation | Equipment Validation | Equipment Calibration | Cleanroom | GMP | sterile manufacturing
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. Provide regular reports to management on the status of facility and equipment maintenance, servicing, calibration and validation tasks. Provide training to staff on facility and equipment procedures.
2. You will be the Principal User on assigned major items of equipment including facility HVAC and other systems.
3. Preparation and execution of validation protocols. Maintenance of the validation schedule and facility regulatory compliance. Performance of routine qualification, calibration and maintenance of equipment.
4. Complete and review quality related documentation including but not limited to validation documents , change controls, incidents/deviations and risk assessments in accordance with GMP and standard operating procedures. Preparation, approval and maintenance of Standard Operating Procedures.
5. Plan and undertake the Validation of new equipment and to advise and assist others in this.
6. Providing out of hours cover for critical equipment alarms as required on a rotational basis.
7. Contribute to the set up and execution the validation schedule for the new facility.
To be successful in your application to this exciting opportunity as the Validation Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences related discipline, or equivalent training and experience.
2. You will be expected to demonstrate the at least some of the following experience: Experience working within cleanroom facilities ideally within a sterile manufacturing environment, experience of managing a validation program in a GMP environment, equipment validation and calibration, preparation of validation protocols.
3. Given the nature of the work carried out on site, you will be expected to have an understanding of UK laws and regulations for cell therapy products and tissue donation.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Eve Hegarty
- Phone: 0131 202 9700
- Reference: J5632045
- Posted: 14th August 2019
- Expires: 11th September 2019