Validation Specialist

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.