Computersystemvalidation Engineer (CSV) (m/w/d)

Ferring Holding SA; Kiel; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Kiel is seeking a Computersystemvalidation Engineer to oversee the validation and compliance of computer systems. This full-time role involves collaboration with project teams, ensuring adherence to GxP regulations, and driving continuous improvement initiatives. Join a supportive and innovative environment focused on making a significant impact in healthcare.

Leistungen

Flexible work arrangements

Competitive pay

Comprehensive health and wellness programs

Career development opportunities

Qualifikationen

• Minimum 3 years in system validation and quality control.
• Experience in biotech, pharma, or regulated industry.
• Knowledge of 21 CFR Part 11, GAMP 5, EU GMP.

Aufgaben

• Monitor validation of computer systems and IT compliance.
• Support project teams in validation document development.
• Conduct risk analyses and support regulatory inspections.

Kenntnisse

Attention to detail

Communication skills

Knowledge of data integrity concepts

Ausbildung

Degree in a scientific or technical field

Tools

MS Excel

Jobbeschreibung

Computersystemvalidation Engineer (CSV) (m/w/d)

Job Overview

Apply now for the position of Computersystemvalidation Engineer (CSV) (m/w/d) at FERRING GmbH in Kiel, Germany. This is a full-time, permanent role focusing on the validation and compliance management of computer systems within a regulated pharmaceutical environment.

Company Background

FERRING GmbH is the German manufacturing arm of the international FERRING Group, headquartered in Saint-Prex, Switzerland. We produce vital pharmaceutical products across various fields including reproductive medicine, endocrinology, urology, pediatrics, and gastroenterology, primarily specializing in sterile dosage forms and peptide hormones. With approximately 450 employees in Kiel, we are committed to innovation, research, and development.

Responsibilities

• Monitor and ensure the validation of computer systems and IT compliance lifecycle in accordance with GxP regulations and company standards.
• Support project teams in planning, developing, reviewing, and approving validation documents and protocols.
• Collaborate with quality assurance and end-users to improve data integrity and management practices.
• Participate in system implementations, troubleshooting, and process improvements.
• Conduct risk analyses, system reviews, and support regulatory inspections.
• Create and update policies, procedures, templates, and forms.
• Research new technologies and industry standards.
• Identify and implement continuous improvement opportunities.

Qualifications

• Degree in a scientific or technical field.
• Experience in biotech, pharma, medical device, or a regulated industry.
• Minimum 3 years in system validation and quality control.
• Knowledge of 21 CFR Part 11, GAMP 5, EU GMP, and data integrity concepts.
• Proven success in cGMP projects and agile validation approaches.
• Advanced MS Excel skills, high attention to detail, and excellent communication skills in German and English.

Benefits & Culture

Ferring emphasizes a people-first approach, offering flexible work arrangements, competitive pay, comprehensive health and wellness programs, family support initiatives, and career development opportunities within a global, innovative environment.

Join us to make a meaningful impact on healthcare and be part of a supportive, inclusive community.

Application Process

Please submit your application via our Workday system, ensuring all documents (cover letter, CV, certificates) are uploaded as a single file.

We look forward to your application!