Senior Validation Engineer – IQ/OQ/PQ Lead

Planet Pharma; Irvine (CA); On-site; USD 66,000 - 80,000; Full time

Job summary

Planet Pharma in Irvine, CA is seeking a Validation Engineer to develop and execute IQ/OQ/PQ/TFIQ protocols for equipment and fixtures. You will draft and revise procedures and documents governing manufacturing and inspection of products, ensuring compliant, well-documented validation activities.

The role requires 5-7 years of engineering validation experience, a Bachelor’s degree in engineering, strong MS Office skills, and excellent written and verbal communication.

Qualifications

• Bachelor’s degree in engineering is required.
• 5-7 years of engineering validations experience.
• Experience with IQ/OQ/PQ/TFIQ protocols and technical writing.
• Proficiency in MS Office and documentation standards.

Responsibilities

• Protocol development for equipment and fixture validations (IQ/OQ/PQ/TFIQ).
• Execution of equipment and fixture validations (IQ/OQ/PQ/TFIQ).
• Report writing of equipment and fixture validations (IQ/OQ/PQ/TFIQ).
• Drafting of procedures and documents related to the manufacturing and inspection of product.
• Drafting/revising procedures and documents related to management of manufacturing/inspection areas.
• Includes planning and executing on deliverables with team members.

Skills

Creativity

Communication skills

Analytical thinking

Problem-solving

Team player

Detail oriented

Validation experience

Protocol development

Technical writing

MS Office

Education

Bachelor’s degree in engineering

5-7 years experience

Tools

MS Office Suite

Job description

Planet Pharma in Irvine, CA is seeking a Validation Engineer to develop and execute IQ/OQ/PQ/TFIQ protocols for equipment and fixtures. You will draft and revise procedures and documents governing manufacturing and inspection of products, ensuring compliant, well-documented validation activities.

The role requires 5-7 years of engineering validation experience, a Bachelor’s degree in engineering, strong MS Office skills, and excellent written and verbal communication.