Description

You will design, implement, and qualify compliant IT solutions for QC, R&D, and manufacturing environments within a regulated GxP framework.

This role is on-site.

Responsibilities

• Design and implement site-specific, regional, and global IT solutions, including detailed design specifications and data flow diagrams.
• Install, configure, and administer computer systems and lab instruments in a GxP environment.
• Execute test scripts and collaborate with vendors and quality teams on IQ/OQ/PQ to qualify IT solutions.
• Manage changes in accordance with GxP and IT change control processes to meet SLAs and KPIs.
• Present solutions to the architecture review board and support enterprise architecture guidelines.

Required Skills

• 8+ years of industry experience supporting biotech or pharma technology solutions in a GxP environment.
• Knowledge of commissioning, qualification, and validation processes.
• Practical experience with IT systems management and IT operational support.
• Proficiency with SDLC, PMM, and Agile methodologies.
• Experience with quality labs and manufacturing instruments, operating systems, and infrastructure configurations.
• Ability to manage system integration and engage stakeholders in an international environment.
• Proven ability to manage multiple competing priorities under indirect supervision.

Preferred Skills

• Strong analytical, problem-solving, and technical communication skills.

Education and Experience

• Master’s degree in Computer Science or Information Systems with 8+ years of experience.

Key Skills

Education

Master’s degree in Computer Science