Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise

Johnson & Johnson; Berlin; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading consulting firm in Berlin seeks a Senior Life Science Consultant specializing in computer system validation and AI solutions. Candidates must have a strong background in validation, including working knowledge of FDA regulations and AI technologies. This role offers flexible working hours, a competitive salary, and excellent professional development opportunities.

Leistungen

Flexible working hours

Home office

Unlimited full employment contract

Substantial bonus

Qualifikationen

• 3+ years experience in Computer System Validation.
• 2+ years experience with System Development Lifecycle.
• Familiarity with FDA regulations and global regulatory environments.

Aufgaben

• Provide consultation for computer system validation and AI solutions.
• Develop and implement AI solutions using technologies like ChatGPT.
• Deliver insights on regulatory differences.
• Develop and execute validation deliverables.
• Review and approve system tests and design specifications.

Kenntnisse

Computer System Validation

AI technologies

FDA regulations understanding

QA methodologies

Attention to detail

Ausbildung

Bachelor’s degree in computer science or related field

Master’s degree

Tools

Open AI's ChatGPT

Jobbeschreibung

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Senior Life Science Consultant - Senior Computer System Validation Consultant with AI Expertise [Berlin, 10115], [Hessigheim, 74394], [Hamburg Hamburg-Altstadt, 20099], [Baden-Baden, 76530], [Bavaria, ], [Bremen, ], Baden-Württemberg, Bavaria, Bremen, Hamburg, Hesse, Berlin - Germany | Posted - 11 / 07 / 23 Overview

We are looking for enthusiasts

KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries withafocus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland, Italy, and Malaysia. With our enthusiasm for progressive technologies and our in-depth knowledge of industrybest practicesand regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us atwww.KVALITO.ch

Senior Life Science Consultant -

Senior Computer System Validation Consultant with AI Expertise

Only candidates located within the European Union (EU) will be considered for this position.

Duration : 6 months (withthe possibility of extension)

We are seeking a highly skilled and motivated senior CSV consultant with expertise in AI to join our team. The ideal candidate should have proven experience with system development, lifecycles, computer system validation, and regulatory standards. Additionally, the candidate should possess extensive knowledge of AL solutions, including using Open AI technologies like ChatGPT, and demonstrate the ability to develop robust testing strategies for these systems.

Responsibilities

Providing consultation services to our clients in the pharmaceutical industry, with a specific focus on computer system validation (CSV) and AI solutions

Develop, implement, and maintain AI solutions using technologies like Open AI's ChatGPT.

Feed internal procedures & documents into AI systems, ensuring the system accurately identifies the source.

Deliver insights on regulatory differences across various countries and present these findings through clear, concise reports and graphical representations.

Develop and execute validation deliverables, including requirements, compliance / validation plans, test protocols, test summary reports, and compliance / validation reports.

Review and approve system tests, user acceptance test scripts, traceability matrices, and design specifications.

Design and understand test plans, system, and UAT test scripts, and test procedures for AI solutions.

Guide validation, conduct timely reviews, and escalate to TQ management when necessary.

Minimum Qualification and Experience

Education

Bachelor’s degree in computer science, Data Science, or a related field.

Master’s degree is preferred.

Language

Fluent in English (oral and written) is a requirement.

Any additional language is plus.

Work experience

3+ years of experience in Computer System Validation.

2+ years of experience with the System Development Lifecycle.

Prior experience in the Pharmaceutical, Biotechnology, or Medical Device industry.

Familiarity with FDA regulations and global regulatory environments.

Understanding of GxP standards and risk-based validation.

Skills

Experience in FDA and / or Global regulated environment with a good understanding of GxP standards and Risk-based validation.

Proficient knowledge of FDA guidance and industry standards (i.e., GAMP).

In-depth knowledge and practical experience with AI technologies, specifically Open AI's ChatGPT.

Proven experience with AI testing strategies and understanding AI models.

QA methodologies and the ability to design, review, and approve test plans, scripts, and procedures.

Strong written and verbal communication skills

Abilityto work as a team player, lead, or complete tasks independently.

Strong attention to detail and ability to ensure data accuracy and reliability.

Capability to work with remote teams and support multiple projects simultaneously.

Exceptional organizational and multitasking skills.

Proven ability to lead a team and work independently.

We offer great benefits

Flat hierarchies and responsibility from the beginning

People-oriented culture

Diversity and inclusion-focused environment

Global client projects in a multinational environment

Flexible working hours and home office

Involvement in global conferences

Individual professional development, training, and coaching

Unlimited full employment contract

Excellent remuneration package consisting of a competitive salary plus a substantial bonus.

Contact

If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application torecruiting(at)kvalito.ch including your :

CV, cover letter, and supporting documents(i.e.,diplomas, certificates, references)

Availability - earliest start date

Salary expectations

Location preference

We are looking forward to your application.

Your KVALITO Team.