Job Title: Validation Specialist
Location: East Grinstead, West Sussex
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Based at the ThermoFisher Scientific Microbiology Division East Grinstead site and reporting to the European Validation Manager, the Validation Specialist will support GMP manufacturing by ensuring all aspects of validation (equipment and facilities qualification, process, cleaning, computerised systems and routine requalification activities) are complete and up to date.
The Validation Specialist will have day to day responsibility for managing validation activities and be expected to administer a harmonised Validation Programme as set out by the European Validation Manager in line with other Divisional European Manufacturing Sites.
You will be part of a growing Validation Team within the Quality Function and be expected to work alongside colleagues in Quality, Manufacturing, Engineering and Regulatory Affairs at East Grinstead and other sites from time to time
- Generating the Annual Validation Schedule once risk, impact and business needs have been assessed with key stakeholders.
- Tracking and maintaining the Annual Validation Schedule and regularly updating progress to the European Validation Manager and Site Leadership.
- To assist the European Validation Manager with preparation and maintenance of the Site Validation Master Plan, Policies, Standard Operating Procedures and training documents.
- Creating and maintaining qualification related records (database/spreadsheet/log), templates, procedures, documents and drawings.
- Engaging with project teams to help with selection, installation and commissioning of new equipment and services.
- Assisting system owners with impact assessments and identifying qualification/validation requirements.
- Preparation and execution of validation protocols through the Validation Life Cycle.
- Carrying out all validation activities on equipment before handover or return to system owner and updating relevant records and schedules.
- Arranging specialist services to qualify specialist equipment.
- Supervising technicians, fitters and contractors as required when external support is utilised for qualification activities.
- Keeping all equipment and processes in a qualified state to support GMP requirements.
- Maintaining validation equipment (data loggers, thermocouples, test instruments) in a state of calibration and compliance to support the company’s validation efforts.
- Represent the business during customer audits and regulatory inspections.
- Ensuring compliance with safety, health and environmental (SHE) legislation.
- Any other task required from time to time to assist the efficient running of the Company’s business.
- Demonstrable validation experience within a GMP environment such as medical devices based on ISO13485, biopharmaceutical, consumer healthcare or related industry.
- Knowledge of 21 CFR Part 820, EudraLex Volume 4, ICH Q series guidance documents, GAMP 5 guide.
- Knowledge of commissioning and equipment qualification to include temperature controlled storage/processing, automated production lines, autoclaves, label and printing systems
- A pragmatic approach to validation with the ability to clearly and confidently communicate with colleagues (written, verbal, visual).
- Proven problem solving skills, diagnosing faults and resolving qualification issues to get the best outcome for the stakeholders and business.
- Excellent planning and time management with the ability to adapt to rapid changes in project priorities and meeting aggressive timelines.
- Demonstrable team player with the ability to work independently and autonomously to support validation projects and communicate progress and any issues via team meetings and project meetings.
- Demonstrated effective interpersonal skills with an ability to interface well at all levels.
- Experienced user of Microsoft Word and Excel
- Opportunities may arise to travel to other manufacturing sites, vendors and customers so a valid driving license will be an advantage, although not essential.