We have an exciting opportunity to strengthen our Validation team and we are looking to fill the full time position of Validation Specialist at Windrush Court, Oxford.
To support GMP manufacturing and laboratory facilities by ensuring all aspects of validation (manufacturing & laboratory equipment, facilities and utilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) are complete and up to date.
The Validation Team also represent the business in customer audits and regulatory inspections to demonstrate compliant systems
For this position, your key responsibilities will be:
Supporting the validation of OXB’s equipment, facilities, utilities and processes in accordance with GMP requirements and a lifecycle approach in coordination with multi-functional Validation Working Parties at OXB, liaising with internal functions including Engineering, Manufacturing, QC, QA and Manufacturing Development. This includes:
Supporting system owners in preparing user requirement specifications (URS), conducting design qualification (DQ) studies and system/equipment selection
Preparing and maintaining validation plans (VPs), assisting system owners with impact assessments and identifying validation requirements
Executing validation protocols (equipment, facilities, utilities, computerised systems and processes)
Managing the provision of validation services with third party providers (including directing, instructing and supervising OEM technicians/fitters and contractors as required) to qualify/requalify specialist equipment
Critically reviewing the results of validation studies and effectively managing/closing-out any deviations
Generating validation reports. before handover/return to system owner and updating all relevant records and schedules
Managing the requalification of systems and equipment in accordance with approved plans and procedures to maintain the ‘validated state’ to support the company’s validation efforts
Maintaining qualification related records, procedures, documents and drawings
Maintaining Validation Master Plans (VMPs) and inventories of GMP critical computerized systems & software ensuring that all such systems are in compliance with Eudralex Volume 4, annex 11 & FDA 21CFR Part 11
Represent the Validation Department during client audits and regulatory inspections
Ensuring compliance with safety, health and environmental (SHE) legislation
Provide validation support to the continuous improvement, company’s expansion & automation projects at OXB in an environment of rapid change
Contribute to proactive management of asset preservation, energy reduction initiatives etc.
Any other task required from time to time to assist the efficient running of the Company’s business
The successful candidate for this Validation Specialist position will have:
Degree (or equivalent) in Science / Engineering or related discipline
Broad knowledge of biopharmaceutical and pharmaceutical industry regulations and guidelines including GMP, GDP, GLP, GEP
Demonstrable validation experience in a biopharmaceutical, pharmaceutical or related industry including Manufacturing/Laboratory Equipment, Facilities & Utilities Qualification (URS, DQ, IQ, OQ & PQ)
Understanding and experience of biopharmaceutical and/or pharmaceutical process validation. Experience of aseptic processing and cleanrooms highly desirable
Computerised systems validation (CSV) experience desirable
Project management methodology approach to work organisation and delivery
Excellent interpersonal and influence skills with an ability to interface well at all levels both within the organisation and with clients and manufacturers.
Good time management skills
Effective communication/presentation skills
Problem solving skills and a continuous improvement mindset
Ability to learn quickly and think laterally
Ability to work independently and with the multi-professional team
Demonstrable ability to prioritise workload in order to meet deadlines
Commitment to achieving personal, departmental and organisational objectives
Willingness to travel and work off site at alternative contract / external sites
Flexible to meet changing service requirements
About the Validation team
The primary function of the Validation Department is to provide evidence that the GxP facilities, equipment and processes employed at Oxford BioMedica are appropriate, robust and compliant. In addition to this the department helps the business to identify and develop bespoke requirements through the preparation of user requirement specifications and functional design qualification.
The Validation Team represent OXB in customer audits and regulatory inspections to demonstrate that we have compliant systems and that OXB collects and maintains suitable records to ensure appropriate Quality Assurance in all activities undertaken and play a central role in demonstrating the successful technical transfer of processes into and / or out of the business.