CSV/Qualification Engineer

OneAPPS Consulting; Halle (Saale); Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

OneAPPS GmbH in Halle, Germany seeks a qualified Engineer to lead IT/OT qualification activities in a cross-functional, international project environment. You will author and execute qualification deliverables including CS, FS, IQ and OQ, and support FAT activities as needed.

Travel of 5-10% across Europe is required. The role emphasizes CSV, regulatory compliance (ALCOA), and collaboration with business teams to develop URS and ensure thorough documentation across sites in Germany and France.

Qualifikationen

• Strong experience in Computer System Validation (CSV) and qualification of IT/OT systems within regulated pharmaceutical environments.
• Experience with qualification documentation, protocol execution, and compliance requirements.
• Ability to work effectively in a cross-functional and international project environment.

Aufgaben

• Experience in qualification, validation, or a related area.
• Supporting business teams in the development of User Requirement Specifications (URS).
• Executing qualification protocols and ensuring complete and accurate documentation of all testing activities.
• Performing validation of IT/OT systems, including interfaces and system integrations.
• Ensuring all qualification and validation documentation complies with ALCOA principles and applicable procedures.
• Supporting CSV activities across both German and French sites, with effective reuse and leveraging of documentation where applicable.
• Working under the direction of the Project Compliance Manager (PCM) and the IT/OT organization.
• Participating in project review meetings and ensuring adherence to project schedules and milestones.
• Contributing to Factory Acceptance Testing (FAT) activities when required.

Kenntnisse

CSV experience

IT/OT systems

Documentation

ALCOA compliance

Regulated pharma

Jobbeschreibung

OneAPPS GmbH (www.oneapps.com) is a Technology consulting firm based out of Germany and offices across Europe. We are working on various projects involving diverse, multicultural teams with clients across the Europe. We are an invaluable partner and our teams have collaborated to support the growth of our clients. With more than 7 locations worldwide we help our clients to deliver their projects smoothly. We look forward to getting to know you and working with you.

Role: Qualification Engineer

Location: Halle, Germany

Travelling: 5-10% of traveling required across Europe.

Job Description:

The Qualification Engineer (QE) will be responsible for authoring and executing IT/OT qualification deliverables, including Configuration Specifications (CS), Functional Specifications (FS), Installation Qualification (IQ), and Operational Qualification (OQ).

Key Responsibilities:

• Experience in qualification, validation, or a related area.
• Supporting business teams in the development of User Requirement Specifications (URS).
• Executing qualification protocols and ensuring complete and accurate documentation of all testing activities.
• Performing validation of IT/OT systems, including interfaces and system integrations.
• Ensuring all qualification and validation documentation complies with ALCOA principles and applicable procedures.
• Supporting CSV activities across both German and French sites, with effective reuse and leveraging of documentation where applicable.
• Working under the direction of the Project Compliance Manager (PCM) and the IT/OT organization.
• Participating in project review meetings and ensuring adherence to project schedules and milestones.
• Contributing to Factory Acceptance Testing (FAT) activities when required.

Preferred Candidate Profile:

• Strong experience in Computer System Validation (CSV) and qualification of IT/OT systems within regulated pharmaceutical environments.
• Experience with qualification documentation, protocol execution, and compliance requirements.
• Ability to work effectively in a cross-functional and international project environment.