Thermal Validation Specialist GMP Compliance

Position: Thermal Validation Specialist for GMP Compliance
Elevate your career at Amaris Consulting as a Thermal Validation & CQV Engineer focused on ensuring GMP compliance. Drive validation activities with precision in a challenging environment.

This role is crucial in leading CQV operations to validate a range of sterilization and decontamination systems. You will be responsible for conducting thorough thermal validation, authoring essential documentation, and collaborating with quality teams to maintain inspection readiness. Your mentorship will enhance the capabilities of junior staff as you promote a culture of continuous improvement.

Key Responsibilities:

• Lead thermal validation and CQV tasks across facilities

• Develop and review comprehensive C&Q documentation

• Execute FAT/SAT and manage validation protocols

• Conduct cycle execution and data analysis accurately

• Implement improvements in annual validation programs

Requirements:

• Bachelor's degree in Engineering, Microbiology, or similar

• 3-6 years of CQV/thermal validation experience

• Familiarity with GMP standards and compliance requirements

• Expertise in Kaye AVS and documentation management solutions

• Exceptional problem-solving and reporting skills

Utilize your skills in thermal validation to ensure that our systems exceed industry standards and regulatory requirements.
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