Job Description

Role Description

Focus: Integration of software with hardware, requirement writing, testing, and risk analysis

Tool Used: Retina for requirements, risk verification, and validation

Required:

• 1-3 years of experience in process validation within a regulated industry (pharmaceutical, medical device, biotechnology, etc.).
• Strong understanding of process validation principles, techniques, and industry standards.
• Familiarity with regulatory requirements (FDA, ISO) and Good Manufacturing Practices (GMP).

Responsibilties:

• Develop, write, review, and execute process validation/process verification protocols and reports.
• Conduct risk assessments and develop validation strategies for new and existing processes.
• Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
• Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions.

Requirements Management:

• Write and refine requirements
• Develop test cases to verify requirements

Validation & Testing:

• Validate customer requirements
• Conduct failure mode effects analysis (FMEA) from a software perspective

Integration:

• Integrate software with hardware systems
• Address software bugs and defects
• Manage defect resolution and write new requirements for future software releases

Risk Management:

• Perform software and cybersecurity FMEA

Collaboration:

• Work cross-functionally with departments: Quality, Regulatory, Operations, Development (both hardware and software)
• Interface with the team in Romania and external vendors or contractors.

Educational Background:

Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master’s degree with 2 years of experience, or a PhD).

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