Job Description:

The role of Data Integrity / CSV Intern is supporting qualification projects focusing on computer system validation (CSV) and data integrity (DI) for laboratory equipment.

Key Responsibilities:

• Assist in the qualification of laboratory equipment to ensure compliance with cGMP standards

• Support the development and execution of qualification protocols (e.g., IOPQ)

• Collaborate with laboratory personnel to troubleshoot and resolve equipment-related issues

• Participate in routine maintenance of laboratory equipment (e.g., User Account Reviews, Backup & Recovery Testing)

• Support efforts to maintain data integrity within laboratory systems and procedures

• Assist in the review and validation of data management practices to ensure compliance with data integrity standards

• Perform related duties as assigned by supervisor

• Maintain compliance with all company policies and procedures

Minimum Qualification:

• MSc/ BSc; Apprenticeship in Natural Sciences, Engineering, or alternatively a comparable education

• Fluent in English

• Excellent computer proficiency e.g. MS Office

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution

Preferred:

• Experience working with pharmacopeia

• Experience with various analytical techniques, preferably in a regulated environment

• Hands on experience with instrument qualification and documentation (e.g., qualification of production plants, laboratory equipment)

• Excellent analytical skills and problem-solving attitude

• Experience with QMS, SAP is an advantage

Required Skills:

Preferred Skills: