(Senior) Software Validation Engineer - Quality Assurance (all genders) (fulltime, regular)

AbbVie; Ludwigshafen am Rhein; Presencial; EUR 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Diverse environment

Open culture

Attractive salary

Mentor onboarding

Flexible work models

Health program

Social benefits

Career opportunities

Development opportunities

International network

Great Place to Work

Descripción de la vacante

AbbVie in Ludwigshafen, Germany, seeks a Senior Software Validation Engineer - Quality Assurance to oversee GxP computerized systems within R&D. You will interpret regulatory requirements, guide risk-based CSV/CSA activities, and ensure inspection readiness through effective lifecycle governance.

Responsibilities include training business partners, aligning on validation planning, reviewing documentation, and supporting audits.

Formación

• Graduated Engineer (FH) or bachelor’s degree in natural sciences with experience in drug product development, production or validation/qualification in pharma.
• Minimum of 5 years of experience in Quality Assurance or related GxP environment such as qualification/validation, documentation or compliance.
• Strong leadership, relationship-building, influence, and excellent interpersonal skills.

Responsabilidades

• Provide interpretation, guidance, and training for software qualifications/validation and regulatory guidelines, including data integrity and AbbVie policies.
• Support IT software projects with Business System Owners and SMEs.
• Advise on risk-based CSV/CSA strategy, validation planning, testing approach, traceability, and documentation expectations for new systems and changes.
• Review/approve software qualification/validation docs and deliverables with minimal supervision.
• Provide guidance and training to RDQA colleagues and partners on CSV/CSA, data integrity, and quality system expectations.
• Defend software qualification/validation during inspections and audits.
• Support responses to inspection/audit findings and CAPA activities.
• Participate in process improvements and development of compliance plans.

Conocimientos

Software validation

Quality Assurance

Regulatory knowledge

Data integrity

English language

German language

Leadership

Training

Documentation

GxP knowledge

Educación

Bachelor's degree

Descripción del empleo

(Senior) Software Validation Engineer - Quality Assurance (all genders) (fulltime, regular)

• Full-time
• Workday Global Grade: 17

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Welcome to AbbVie! As part of an international company with ca. 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as (Senior) Software Validation Engineer Quality Assurance (all genders)

The (Senior) Software Validation Engineer - Quality Assurance (QA) provides quality oversight and subject matter expertise for GxP computerized systems across GMP, GLP, GCP, and PV-regulated areas within the R&D organization. The role is responsible for interpreting regulatory and quality requirements, guiding risk-based software validation and Computer Software Assurance (CSA) activities, supporting data integrity compliance, and ensuring inspection readiness through effective validation lifecycle management, governance, training, and business partner support.

Make your mark:

• Provide interpretation, guidance, and training for business partners regarding software qualifications / validation and related regulatory regulations / guidelines, including data integrity and AbbVie policies / procedures.
• Support Business System Owner and Business SME with their IT software projects and goals.
• Advise project teams, Business System Owners, and Business SMEs on risk-based CSV / CSA strategy, validation planning, testing approach, traceability, and documentation expectations for new systems and system changes.
• Review / approve various software qualification / validation documentation, summaries, and certification packages and associated deliverables as appropriate with minimal supervision.
• Provide technical guidance, coaching, and training to RDQA colleagues and business partners on CSV / CSA, data integrity, validation, and quality system expectations.
• Defend software qualification / validation during regulatory authority inspections and third-party audits.
• Support business in understanding the process of inspection/ audit responses.
• Recommend a plan of action for satisfactory resolution of quality and regulatory compliance issues.
• Participate in CAPA activities, provide support to event owners and Business System Owners, review and approve related records.
• Provide guidance, direction, and support to R&D QA staff.
• Participate in process improvement projects and assist with the development of compliance plans and strategies.

This is how you make a difference:

Required Qualification

• Graduated Engineer (FH) or bachelor's degree in natural sciences, several years of experience in drug product development or production or validation / qualification in the pharmaceutical field.
• Minimum of 5 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification / validation, documentation, or compliance.
• Key leadership competencies to include relationship-building, ability to influence, knowledge of the business, sound judgment, conflict resolution, excellent interpersonal skills.
• Ability to provide innovative ideas to improve quality and compliance that create value, always seeking new information and insights (internal and external).
• Excellent communication capabilities and teamwork capacities, on a local and global level.
• Excellent knowledge of the English and the German language (spoken and written).

Preferred Qualification

• Experience with development, oversight, validation, or governance of AI/ML-enabled technologies, advanced analytics platforms, automation solutions, or digital quality systems, including application of risk-based assurance and data integrity principles.
• Knowledge of emerging industry guidance related to AI/ML, computerized systems quality, and digital health technologies.

What we offer you:

• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy work-life balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with top-tier, attractive development opportunities
• with a strong international network

At multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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