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GSK • Gödöllő, Central Hungary, Hungary
Role & seniority: Validation Standards Specialist (mid-level specialist)
Stack/tools: Validation lifecycle for equipment, utilities, cleaning and computerized systems; MS Office; document management systems; familiarity with regulatory guidance and risk-based validation; CSV/automation experience a plus.
Define, maintain and communicate site validation standards and guidance across equipment, utilities, cleaning and computerized systems.
Review and approve validation plans, protocols and reports to ensure regulatory and company compliance.
Support audits/inspections (prepare evidence, respond to findings, implement corrective actions) and maintain the Site Validation Master Plan; drive tool/process improvements.
Degree in engineering, life sciences, pharmacy or related field; minimum 3 years in validation/quality in regulated manufacturing.
Practical knowledge of validation lifecycle for equipment, utilities, cleaning and computerized systems.
Experience preparing/reviewing validation plans, protocols and reports; good English communication; MS Office; document management systems.
Advanced degree; pharmaceutical/biological manufacturing site experience; familiarity with regulatory requirements and industry guidance; audits/inspections experience; risk-based validation and statistical methods; CSV or automation system experience.
Location & work type: Gödöllő, Hungary; Hybrid (
As Validation Standards Specialist, You will help set and maintain validation standards that keep our manufacturing operations compliant, safe and fit for purpose. You will work with engineers, quality, operations and project teams to define validation approaches, review plans, and support continuous improvement. We value clear communicators who take responsibility, challenge constructively, and build practical solutions. This role offers visible impact, professional growth, and a chance to advance GSK’s mission of uniting science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Define, maintain and communicate site validation standards and guidance across equipment, utilities, cleaning and computerised systems. Review and approve validation plans, protocols and reports to ensure compliance with regulatory and company expectations. Support cross-functional projects by advising on validation strategy and lifecycle requirements. Maintain and update the Site Validation Master Plan and validation-related procedures. Support audits and inspections by preparing evidence, responding to findings and implementing corrective actions. Drive incremental improvements in validation tools, templates and ways of working. Why You? Basic Qualifications & Skills: We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Degree in engineering, life sciences, pharmacy or similar technical discipline. Minimum 3 years’ experience in validation or quality roles within a regulated manufacturing environment. Practical knowledge of the validation lifecycle for equipment, utilities, cleaning and computerized systems. Experience preparing or reviewing validation plans, protocols and reports. Good English communication skills. Hungarian language skills are an advantage. Proficient user of MS Office applications and experience with document management systems. Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus Advanced degree in engineering, bioscience or related field. Experience working in pharmaceutical or biological manufacturing sites. Familiarity with current regulatory requirements and industry guidance on validation. Experience supporting audits and inspections. Knowledge of risk-based validation approaches and statistical methods. Experience with computerized system validation (CSV) or automation systems. What we offer: Hybrid working (2 days in HO per week) with flexible working hours Permanent contract Annual bonus and annual salary review Cafeteria (flexible benefits) Commuting support (company shuttle buses from Budapest and surrounding towns of Gödöllő, or fuel support if using your own car) Group life and accident insurance package Voluntary pension fund contribution Paid parental and caregiver leave Modern and clean working environment with an innovative culture For further information watch our video summarizing our benefits: GSK Gödöllő juttatások (youtube.com) #LI-Hybrid Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any specific adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on . Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels’. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.