Senior CSV / CSA Validation Consultant
Arcondis Solutions s.r.o.
Košice
full-time
ASAP
2 200 - 3 000 EUR/month
Information about the position
Job description, responsibilities and duties
We are looking for a Senior CSV / CSA Validation Consultant to strengthen and expandArcondis’ capabilities in Computer System Validation (CSV), Computer Software Assurance (CSA), and digital compliance services within the life sciences industry.
In this role, you will support international projects across pharmaceutical, biotechnology, and medical device environments, helping customersvalidatedigital systems, laboratory and manufacturing platforms, equipment software, and emerging technologies within regulatedGxPenvironments.
You will contribute to project delivery, customer-facing advisory activities, and the continued evolution of modern validation approaches, including risk-based validation, digital quality, and AI-enabled technologies.
This position offers the opportunity to work closely with global teams across Europe, APAC, and the US while supporting customers in solving complex compliance and validation challenges in an increasingly digital environment.
Employee perks, benefits
- Referral bonus depending on level of person referred
- Business mobile (also for private calls) and laptop
- 3 sick days per calendar year
- 2 extra days off for your wedding
- Social events (team-buildings and team-dinners)
- Budget for trainings & certifications
- Monthly events in Kosice (office)
- Free snacks & drinks in the office
- Home Office upon agreement (or possibility to work from our office in Kosice)
- Flexible working hours
- Ice Hockey ticket discounts
- Supplementary pension scheme (the third pilar) contribution
- Benefit card
- On - calls paid beyond the law
- Meal allowance beyond the law
- Company bonus (based on company financial results)
Requirements for the employee
Minimum education required
Educational Specialization
Language skills
Other knowledge
Cloud computing - Basic
Azure DevOps Server - Basic
Experience in the position/sector
Number of years of experience
Personality requirements and skills
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, Quality Management, or a related field; a Master’s degree is considered an advantage
- 5+ years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), digital validation, or compliance-related activities within regulated life sciences environments
- Strong understanding of GxP regulations, GAMP 5, EU GMP Annex 11, 21 CFR Part 11, data integrity principles, risk-based validation approaches, and quality management systems
- Experience working within pharmaceutical, biotechnology, and/or medical device environments
- Experience validating GxP computerized systems and digital platforms across laboratory, manufacturing, quality, ERP, or cloud-based environments
- Experience authoring and reviewing validation lifecycle documentation, including validation plans, requirements, risk assessments, test documentation, traceability matrices, deviations, change assessments, and validation reports
- Understanding of software development lifecycle (SDLC), Agile/DevOps environments, automated testing, and modern CSA approaches is considered an advantage
- Experience with AI/ML-enabled systems, cloud validation, Digital QC, medical device quality standards, or automated production systems is considered an advantage
- Experience supporting audits, inspections, supplier assessments, CAPA activities, data integrity initiatives, or compliance remediation programs is considered an advantage
- Strong communication and stakeholder management skills with the ability to work in international and cross-functional environments
- Ability to work independently, manage customer interactions, and contribute to both technical and business discussions
- Interest in supporting customer workshops, service development, and business growth initiatives