About the role

This role involves the development, implementation, and execution of validation activities for small-scale equipment and related software.

The successful candidate will conduct validation studies for cGMP-critical process systems, ensuring compliance with cGMP, user, and regulatory requirements.

This position requires hands-on involvement in qualification of systems, interpreting industry standards, and maintaining compliance with cGMP, cGLP, and specific procedures. You will also provide technical assistance on current US FDA and EU validation requirements, ensuring projects align with all necessary regulatory standards

Key responsibilities 

• Develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities for equipment
• Conduct validation studies to demonstrate compliance with cGMP and regulatory requirements
• Perform qualification of systems, interpreting standards to specific cases
• Ensure systems maintain qualified status in compliance with cGMP at all times
• Provide technical assistance on US FDA and EU validation requirements
  
  

About you

• Strong knowledge of cGMP requirements in a regulated environment
• Understanding of relevant quality and compliance regulations
• Ability to troubleshoot validation issues effectively
• Proficiency in quality management systems
• Experience in qualification of small-scale equipment and related software