QA Specialist – Validation & Commissioning

About the role

CAI is seeking a QA Specialist to support validation, commissioning and qualification activities for FDA‑regulated products in the pharmaceutical, medical device and biotechnology sectors. You will work closely with the Validation Manager and cross‑functional teams to ensure projects are delivered on time, within budget and to the highest quality standards.

Key responsibilities

• Assist the Validation Manager in planning, executing and closing validation projects.
• Support testing and validation of equipment, cleaning processes, analytical methods and software.
• Develop, review and approve validation plans, protocols and reports.
• Identify risks, conduct risk assessments and propose mitigation strategies.
• Maintain validation documentation in compliance with company policies and regulatory requirements.
• Coordinate with cross‑functional teams to ensure clear communication throughout the project lifecycle.

Required profile

• Experience in commissioning, qualification and validation within pharma, medical device or biotech industries.
• Strong understanding of FDA‑regulated environments and related standards.
• Ability to work collaboratively with multidisciplinary teams.
• Excellent organizational and communication skills.

Required skills

• Validation methodology
• Risk management and risk assessment
• Regulatory compliance (FDA, GMP)
• Documentation control

What we offer

• Exposure to cutting‑edge technologies in advanced medicine.
• Opportunities to work with subject‑matter experts on lifesaving therapies.
• Professional training, certifications and career development support.
• Employee‑owned culture that values teamwork and integrity.