Brightwork are currently recruiting for a Validation Specialist to join our client, a renowned manufacturer in their site in Ayrshire during an exciting period of expansion and growth.

The Validation Specialist responsibilities include:

Leadership role within the Quality Department responsible for the management and co-ordination of the site cGMP validation activities.
Support validation activity during design, installation & commissioning of new equipment, processes, packaging lines & facilities and utilities.
Ensure the validated status of site facilities, i.e., equipment, processes, CSV and utilities is complete and compliant with internal local and corporate procedures, relevant regulatory requirements and industry guidance.
Authoring, reviewing, executing and maintaining validation documentation including site Validation Master Plan and Site Validation Strategy.
Support Production departments in validation activities for processes and equipment.
Preparation and management of validation plans, protocols and reports.
Supporting external audits including customer and regulatory inspections, presenting and explaining relevant validation information to inspectors/auditors.
Execute validation protocols and drive to completion any CAPA associated with non-conformances raised.
Use quality risk management tools (e.g., FMEA, System Impact Assessments) to ensure that risks are appropriately identified, documented and managed.
Ensure product quality through robust testing and process monitoring including the use of statistical techniques.

Successful candidates should have a degree in a relevant science or engineering discipline along with validation and qualification experience in a cGMP regulated life science industry, i.e., Pharmaceutical, API or Bio-tech. Other essential behaviours are excellent communication and organisational skills, and the ability to work independently & within cross functional teams.

Brightwork is a recruitment agency for those seeking permanent work and a recruitment business for those seeking temporary work.