Job Title: Validation Specialist
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 $17
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.
For this position, your key responsibilities will be:
- Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support GMP requirements
- Preparation and execution of validation protocols (equipment, cleaning, computerised systems and processes)
- Assisting system owners with impact assessments and identifying qualification/validation requirements.
- Carrying out all validation activities on equipment before handover/return to system owner and updating all 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
- Maintaining validation equipment in a state of calibration and compliance to support the company’s validation efforts
- You will also represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems.
- Creating/maintaining qualification related records, procedures, documents and drawings
- Ensuring compliance with safety, health and environmental (SHE) legislation
- Engaging with project teams to help with selection, installation and commissioning of new equipment
- 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:
- At least 3 years validation experience within a GMP environment
- Demonstrable validation experience in a medical device ISO13485, biopharmaceutical (chromatography, ELISA), consumer healthcare or related industry.
- Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA
- Knowledge of commissioning and equipment validation to include autoclaves, temperature controlled storage and automated production lines, cleaning validation experience
- Proven problem solving skills/diagnosing faults/resolving qualification issues
- Excellent planning and time management ability
- The ability to adapt to rapid changes in project priorities and meeting aggressive timelines
- 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. Good oral and written communication skills
- A valid driving license.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story
to tell. Join us and contribute to our singular mission—enabling our customers to make the
world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate
on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin,
protected veteran status, disability or any other legally protected status.