(Senior) Specialist PV Systems & DA

Boehringer Ingelheim Pharma GmbH & Co. KG; Ingelheim am Rhein; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Boehringer Ingelheim, a global leader in healthcare, seeks a Senior Specialist PV Systems and Data Analysis to strengthen PV operations at our Ingelheim site. You will support PV systems, drive change controls, and guide users to retrieve data efficiently.

As a Subject Matter Expert, you will lead improvements, mentor users, and oversee Change Advisory Board activities while ensuring compliance with regulatory standards and quality processes.

Qualifikationen

• Bachelor's degree in biology, statistics or IS/IT or apprenticeship with additional education or comparable long-term experience.
• Several years of experience with GxP systems with a focus on data analysis is preferred for senior roles.
• Experience with PVWorks, GoTrack, or similar validated databases.
• Regulatory and/or Quality Compliance experience.
• Proficiency with Microsoft Office products, especially advanced Excel charting.
• Fluent in spoken and written English.

Aufgaben

• Support PV systems and contribute to change control processes for compliance and continuous improvement.
• Administer PV systems across development, validation, production, and training environments.
• Guide global PV users and assist with data retrieval and system navigation.
• Ensure systems comply with corporate procedures and regulatory requirements.
• Investigate and resolve Level 1 system issues and monitor automated processes for reliability.
• Lead PV systems change controls and drive improvements as a Subject Matter Expert.
• Train users and lead the Change Advisory Board; handle Level 2 issues.

Kenntnisse

Pharmacovigilance knowledge

PV systems experience

Excel advanced charts

English fluency

Ausbildung

Bachelor's degree in biology, statistics or IS/IT

Advanced degree preferred (MSc, MBA)

Tools

PVWorks

GoTrack

Jobbeschreibung

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long‑term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.

Tasks & responsibilities

• As part of your role, you will actively support PV systems and contribute to change control processes, ensuring smooth operations and continuous improvement.
• You will provide assistance in the administration of PV systems across all environments, including development, validation, production, and training.
• Moreover, you will guide and support global PV users, helping them navigate system functionalities and fulfill their data retrieval needs efficiently.
• Your responsibilities will include ensuring that the system remains compliant with corporate procedures and meets the requirements of various regulatory authorities.
• You will take ownership of investigating and resolving Level 1 system issues, ensuring timely and effective solutions.
• Additionally, you will execute routine tasks, such as monitoring automated processes, to maintain system reliability and performance.

Additional tasks for Senior Specialist PV Systems and Data Analysis

• As Senior Specialist PV Systems and Data Analysis, you will act as a Subject Matter Expert for PV systems, providing expertise and guidance.
• You will take the lead in implementing PV systems change controls and driving improvements.
• As part of your responsibilities, you will guide and train users, empowering them to utilize the system and retrieve the data they need.
• You will also lead the Change Advisory Board, coordinating and overseeing change management activities.
• Additionally, you will be responsible for investigating and resolving Level 2 system issues, ensuring solutions to maintain system reliability.

Requirements

• Bachelor's degree in biology, statistics or IS/IT or apprenticeship with additional education or comparable long‑term experience
• Few years of experience working with GxP systems with a focus on system support
• Pharmacovigilance Knowledge
• Experience working with PVWorks, GoTrack, or similar validated databases
• Regulatory and / or Quality Compliance experience
• Proficiency with Microsoft office products, specifically advanced graphing in Excel
• Fluent in spoken and written English

Additional requirements for Senior Specialist PV Systems and Data Analysis

• Bachelor's degree in biology, statistics or IS/IT or apprenticeship with additional education or comparable long‑term experience, advanced degree preferred (e.g.: MSc, MBA)
• Several years of experience working with GxP systems with a focus on data analysis
• Experience with Dataland and Dashboards

As part of our commitment to transparency and fairness, salary information will be shared during the recruitment process. We also offer a comprehensive benefits and wellbeing package.

Applications from persons with severe disabilities are warmly welcomed. In cases of equal qualifications, such applicants will be given preferential consideration in the selection process.

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: [phone] or via mail: [e-mail]