Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer!
Location
Vilnius
How will you make an impact?
As a member of the Equipment Qualification team, you will be accountable for the validation of computerized systems to ensure they meet customer and regulatory requirements.
What will you do?
Maintain the validation schedule and keep processes in a qualified state to support GMP requirements;
Preparation and execution of validation protocols (computerised systems);
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;
Assessing and defining assigned validation projects. Maintain the validation schedule and keep all systems in validated state to support ISO and/or GMP requirements.
Writing, reviewing, and implementing procedures and qualification protocols for standard & customized equipment, systems and facilities.
Raise discrepancies and closeout test documentation.
Prepare validation summary reports for completed protocols.
Conduct deviation investigations. To Identify & implement the appropriate corrective actions.
Act as point of contact for validation with internal clients (site-based).
Supervising technicians, fitters, and contractors as required when external support is used for qualification activities.
How will you get here?
Education
Mechanical/Automatic/Electronic/Information Technology or similar Engineering Degree.
Equivalent combinations of education, training, and relevant work experience may be considered.
Experience
Validation experience within a ISO/GMP environment would be beneficial.Knowledge, Skills, Abilities
Good understanding of ISO 9001, ISO 13485, cGMP, GDP, and regulatory requirements for computerized systems (CSV)
Good English spoken and written language skills.
Ability to read and understand technical drawings, instructions, diagrams, etc.
Attention to detail and ability to identify and remediate issues found during validation.
Highly effective verbal and written skills.
Proficient in Microsoft Office applications, particularly Microsoft Word, Excel, Outlook.
Self-motivated and proactive with confirmed time-management skills.
Excellent planning and time management ability;
The ability to work independently and autonomously to support validation projects.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
Compensation and Benefits
The salary range estimated for this position based in Lithuania is –.
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.