Quality Validation Engineer

For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.com with the following:

1) Word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

Job Description

The Quality Validation Engineer is responsible for the validation documentation of equipment, processes, methods, and software, including Master plans, IQ/OQ/PQ, and Final Reports. This role involves executing validation protocols and writing final reports while ensuring adherence to Quality System Regulations and ISO standards. The engineer facilitates improvements and oversees quality control in product design and manufacturing processes. They support R&D and Operations throughout all product development phases, developing process qualification activities, statistically sound sampling plans, and process control plans, including inspection/test method development.

Responsibilities

• Create and maintain validation documentation for equipment, processes, methods, and software.
• Execute validation protocols and write comprehensive final reports.
• Ensure compliance with Quality System Regulations and ISO standards.
• Facilitate improvements in quality control product design and manufacturing process control.
• Support R&D and Operations during product development phases.
• Develop process qualification activities and statistically sound sampling plans.
• Design process control plans, including inspection/test method development.

Essential Skills

• Proficiency in ISO standards and validation processes.
• Effective risk assessment and analysis skills.
• Hands-on experience in IQ/OQ/PQ validation and protocol writing.
• Knowledge of Cleanroom and Equipment validation.
• Experience with Quality Management Systems (QMS).
• Familiarity with Minitab and CAPA.
• Expertise in root cause analysis and regulatory compliance.
• Understanding of automation and GMP practices.

Additional Skills & Qualifications

• Bachelor's Degree in a relevant field.
• 2-5 years of experience in a Quality Validation role.
• Experience and knowledge in Good Manufacturing Practices (GMPs) and Quality Systems.
• Experience in a regulatory environment (e.g., GMPs, ISO9001, ISO13485).
• Experience with validation documentation and executing protocols.
• ASQ Certified Quality Engineer preferred.