Protagen Protein Services GmbH is a world leading CRO in protein analytics and its application to GMP-compliant characterization of protein therapeutics with sites in Heilbronn and Dortmund. We support our customers from pharmaceutical, biopharmaceutical and biotechnology industries providing a wide range of protein characterization services. The expertise, the motivation and enthusiasm of our employees are the guarantee for our success.

 

In order to strengthen our team in Heilbronn we are seeking an

IT Validation Manager (m/f)

Your responsibilities

• Manage, control and implement IT validating projects performed consistent with applicable regulatory requirements (GMP) and internal procedures
• Close cooperation and coordination of validation activities with IT, Quality Assurance and Quality Control, as well as external partners
• Generate and review relevant validation documentation and company statements according to GMP and internal policies mainly in English language
• Execute all relevant validation protocols and test procedures
• Survey of the validation requirements and the corresponding statistical methods
• Correspondent during inspections and audits, as well as for subcontractors and service providers

Your profile

• Degree in applied sciences (Chemistry, Biotechnology, Pharmacy), computer science or engineering
• Minimum 2 years´ industrial experience in IT Validation ideally within the pharmaceutical business
• Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, and GAMP standards is required
• Project management and organizational skills as well as social competencies
• Conduct independent, result oriented and confident communication in international environment
• Fluent German and English language skills

Our offer

• A motivating working environment where your initiatives and strengths are appreciated
• Diverse and interesting assignments
• Optimal training across sites and individual development opportunities

We are pleased to receive your complete application documents via email (HR@ProtagenProteinServices.com) as well as your earliest starting date and salary expectations. Please provide all relevant documents in one or two PDF files.

Protagen Protein Services GmbH
Dr. Petra Weingarten, Director Human Resources
Tel: +49 231 9742 6100; www.ProtagenProteinServices.com

Inselwiesenstraße 10
74076 Heilbronn
Germany