Senior Validation Engineer (Fixed-Term)

THERMO FISHER SCIENTIFIC

Подробности
Основная информация
Компания

Join our collaborative team as a Senior Validation Engineer at Thermo Fisher Scientific, where you'll play a key role in ensuring compliance, quality, and operational excellence across our facilities. In this senior-level position, you will lead complex validation projects, provide technical expertise, and drive continuous improvement initiatives to support pharmaceutical manufacturing, laboratory operations, and quality systems in accordance with global regulatory requirements.

What will you do?

Lead and manage validation and qualification projects, ensuring timely execution and compliance with GMP, ISO, and company requirements.
Develop validation strategies and provide technical guidance for equipment, facilities, utilities, computerized systems, and process validation activities.
Author, review, approve, and execute validation documentation, including validation plans, risk assessments, IQ/OQ/PQ protocols, deviations, change controls, and summary reports.
Serve as a subject matter expert (SME) for qualification and validation activities, supporting site operations, quality, engineering, and regulatory inspections.
Drive risk-based validation approaches and ensure alignment with industry best practices, including FDA, EU GMP, and GAMP5 requirements.
Lead deviation investigations, root cause analysis, and implementation of effective corrective and preventive actions (CAPAs).
Ensure validation lifecycle management and maintain equipment, systems, and facilities in a validated state.
Mentor and provide technical leadership to Validation Engineers and other cross-functional team members.
Coordinate and oversee contractors, vendors, and external service providers supporting qualification and validation activities.
Lead audits and regulatory inspections, including preparation, response development, and implementation of corrective actions.
Identify and implement process improvements to enhance compliance, efficiency, and validation effectiveness.

Requirements:

Bachelor's degree or higher in Engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or a related technical field.
5+ years of validation experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or related industry.
Advanced knowledge of cGMP, FDA, EU GMP, ISO standards, and GAMP5 principles.
Extensive experience developing and executing IQ/OQ/PQ protocols and validation lifecycle documentation.
Demonstrated experience leading validation projects independently and managing multiple priorities simultaneously.
Strong expertise in risk assessments, deviation investigations, root cause analysis, and CAPA implementation.
Experience supporting regulatory inspections and internal/external audits.
Excellent technical writing, documentation, and communication skills.
Strong analytical and problem-solving abilities with a focus on quality and compliance.
Experience mentoring junior engineers and providing technical leadership within cross-functional teams.
Proficiency with quality management systems and Microsoft Office applications.
Fluent in English and Lithuanian, both written and spoken.
Ability to work in controlled environments, including laboratories and cleanrooms, when required.

Salary

2891-4335 gross/month

The final offer will depend on the candidate’s experience, skills, and competencies.

What we offer

Annual performance bonus and additional financial benefits
Comprehensive health package, including private health, life and accident insurance
Wellbeing support for employees and their family members, including mental health consultations, health check-ups, vaccinations, and on-site health initiatives
Opportunities for professional growth through internal training, access to Thermo Fisher e-University, and continuous development
The opportunity to work in a global, innovation-driven organization and collaborate with international teams
Daily benefits such as subsidized meals, gym access, and company transportation
An inclusive and supportive culture, with team events and community initiatives
2 additional paid volunteering days per year

Брутто-зарплата в месяцБрутто/мес. € 2891 - 4335

Место работы

Vilnius, Vilniaus apskritis, Литва

Тип работы

Полный рабочий день

Языки

Английский

Контактное лицо
Daiva Pukėnienė

Thermo Fisher Scientific“ kuriame sprendimus, padedančius žmonėms gyventi sveikesniame, švaresniame ir saugesniame pasaulyje. Tai ne tik mūsų misija – tai kasdienis darbas, kuriantis vertę pacientams, mokslui ir visuomenei.

Thermo Fisher“ padalinyje Vilniuje kuriame, gaminame ir pasaulio rinkoms tiekiame inovatyvius sprendimus gyvybės mokslų tyrimams ir diagnostikai. Čia dirba 1 400 profesionalų, o Mokslinių tyrimų ir eksperimentinės plėtros centre – 180 mokslininkų ir tyrėjų, kuriančių ateities sprendimus.

Puoselėjame įsitraukimu, pasitikėjimu ir bendradarbiavimu grįstą kultūrą, kurioje kiekvienas gali matyti savo darbo prasmę. Skatiname nuolatinį tobulėjimą ir augimą – tiek profesinį, tiek asmeninį.

Prisijunk prie Thermo Fisher“ komandos Vilniuje – čia mokslinės idėjos tampa pasaulį keičiančiais sprendimais, o karjera įgauna aiškią kryptį.

Вебсайт компании: http://www.thermofisher.lt