Senior Computer System Validation Specialist

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Job Description

The Future Begins Here

At Takeda, we are creating a future-ready organization that uses data and digital to meet the needs of patients, our people, and the planet.

We need your help to make this happen. Join our new Innovation Capability Center (ICC) in Bratislava, Slovakia.

In this role at our state-of-the-art center, you will have the opportunity to grow your skills and create solutions that will benefit patients around the world. Become the heart of our internal innovation engine.

At Takeda we unite in diversity! 

Takeda is committed to creating an inclusive workplace, where individuals are recognized for the diverse backgrounds and abilities they bring to our company. We are continually improving workplace experience and accessibility for everyone, and welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our Team.

We are seeking a highly skilled and experienced Senior Computer System Validation (CSV) Specialist to independently lead and manage CSV/CSA projects, focusing primarily on IT systems such as ERP platforms, automation technologies, and enterprise solutions. Exposure to laboratory and R&D systems is a plus, but not the primary focus. This role requires an individual with a strong technical background, deep knowledge of industry standards and regulations, and the ability to drive projects autonomously. If you are passionate about ensuring compliance, data integrity, and quality in computerized systems, we invite you to join our team.

Key Responsibilities:

• Independently lead and execute computer system validation (CSV) projects for IT systems, including ERP platforms, automation technologies, and enterprise-wide computerized systems.
• Develop and implement comprehensive validation strategies in alignment with regulatory requirements, company policies, and established procedures (e.g., GAMP , 21 CFR Part 11).
• Ensure compliance with global CSV/CSA regulations and data integrity requirements for computerized systems.
• Collaborate with cross-functional teams to facilitate smooth project delivery while adhering to quality standards.
• Resolve technical challenges and provide timely solutions for validation-related issues.
• Review and approve CSV documentation, such as validation plans, protocols, reports, and risk assessments, ensuring adherence to internal policies and regulatory guidelines.
• Conduct audits to ensure adherence to quality standards, company procedures, and regulatory expectations.
• Stay updated on trends and changes in regulations, standards, and advancements related to IT systems, AI, ERP, and automation technologies.
• Exposure to laboratory and R&D systems is advantageous but not required.
• Provide guidance and mentorship to junior team members when necessary.

Qualifications:

• Minimum of 5+ years of proven experience in a similar role, showcasing the ability to manage projects independently.
• Bachelor’s or Master’s degree in a relevant scientific or engineering discipline (e.g., Computer Science, Engineering, Chemistry, Pharmacy, or related fields).
• Strong expertise in computer system validation for IT systems, ERP platforms, and automation technologies.
• Proficient in qualifications and validations of computerized systems, from planning to delivery.
• Solid understanding of regulations, guidelines, company policies, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP, 21 CFR Part 11).
• Exposure to laboratory and R&D systems is desirable but not essential.
• Exceptional analytical and problem-solving skills.
• Excellent communication and collaboration abilities for effective stakeholder engagement.
• Attention to detail and commitment to data integrity and quality.

Preferred:

• A track record of successfully managing complex projects independently.
• Experience mentoring and developing junior team members within CSV environments.

What Takeda Can Offer You

At Takeda, you may build your career, while contributing to better people’s lives. Expect trust driven culture built around Integrity, Fairness, Honesty and Perseverance. Joining ICC will give you access to high end technology, training and colleagues who will support your growth.

Salary

As a motivated employee, you should be compensated appropriately. The minimum salary for this position is € 2650 per month (full time), but your final remuneration package may be higher depending on your qualifications and experience.

Benefits

Here are a few benefits our employees are enjoying at Takeda. To get a full picture of what we are offering, follow this link.

• Cafeteria
• Medical - High standard medical care
• Bridge days
• Summer Hours
• Multisport Card

Your application and any and all conversations that occur with the recruiter, HR, and the hiring manager as part of that application will be treated in the strictest confidence.

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