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Validation Specialist

MidlothianPermanent
Experience Dependant
Job Reference: J5632045
Updated On: 07/11/2019
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Medical Device, Contract Manufacturing Organisation, Nutraceutical, Life Sciences, Cell & Gene Therapy, Bioprocessing, Science

Skills: Engineering - Biochemical, Engineering - Validation Perm, Quality Assurance - Validation, Engineering - Pharmaceutical, Engineering - Bioprocess (biotech or biopharma), Validation - Process Validation, Validation - Equipment Validation, Validation - Cleaning Validation, Validation - Facilities/Utilities Validation

Job Information

Role Overview

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. Plan, manage and execute (as appropriate) validation activities to include facility and equipment validation, qualification and re-verification. Provide regular reports to management on the status of validation tasks.

2. Preparation and execution of validation protocols and reports. Management and performance of routine qualification, calibration and maintenance of equipment.

3. Supervision of a small team undertaking planned and preventative maintenance and validation activities for facilities and 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.

5.. Ensure that confidentiality of all information relating to clients and patients is maintained at all times. Communicate procedures and results with clients.

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.

Role Requirements

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 experience with cleanroom facilities, manufacturing and QC testing equipment. In addition, we are looking for someone who can demonstrate experience of managing a validation program in a GMP environment, as well as experience supervising or managing a small team. Ideally the listed experienced will have been gained in a sterile manufacturing facility.

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.
Eve Hegarty
Your Recruitment ConsultantEve Hegartyeve.hegarty@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.