CSV engineer - Hamburg, Deutschland - Optimus Life Sciences

Beschreibung

Job Title: Senior CSV Engineer

Employment Type: Contract / Freelance

Duration: 9+ Months

Location: Hamburg Area, Germany

Responsibilities:

• Responsible for ensuring orderly workflow in regulated qualifications and validations of computerised systems
• Actively involved in developing validation guidelines and SOPs
• Contribute to user requirements and process descriptions.
• Develop qualification and validation plans, including risk analyses
• Manage qualification environments throughout system lifecycle
• Coordinate CSV measures during qualification and rollout
• Ensure compliance with Data Integrity standards
• Coordinate qualification and validation measures and report on progress
• Collect, review, and archive qualification documents and raw data
• Initiate and coordinate corrective measures as needed
• Collaborate closely with various departments
• Promptly inform superiors of significant deviations or events.

Requirements:

• Bachelor's/Master's degree in a technical field (e.g., biological sciences, engineering, biotechnology, quality assurance) from a recognized university.
• 7+ years of experience in pharmaceuticals or related GMP environments.
• Understanding of deviation and change control management, including CAPA.
• Practical knowledge of quality, CSV, and system qualification.
• Strong proactive and planning abilities.
• Fluency in English required. Proficiency in German preferred.

Are you up for an exciting challenge? Then please apply below with an updated CV as soon as possible.

If you have any questions, please reach out at