Pharma Process Validation Engineer – PPQ & CPV Expert

Kindeva Drug Delivery; Missouri; On-site; USD 110,000 - 150,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Process Validation Engineer to lead validation activities across PPQ and CPV, ensuring robust, compliant manufacturing for pharmaceutical and sterile injectable products. You will collaborate with Manufacturing, Quality, Process Development, Engineering, and Regulatory Affairs to drive process performance and lifecycle management.

The role requires 5+ years in pharma manufacturing, strong statistical and technical writing skills, and experience with validation,

Qualifications

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or related field.
• 5+ years in pharmaceutical, biopharmaceutical, or sterile injectable manufacturing.
• Experience with process validation, PPQ execution, CPV, technology transfer, or manufacturing support.

Responsibilities

• Author and execute PPQ protocols, reports, sampling plans, and validation documentation.
• Coordinate validation activities with Manufacturing, Quality, and Engineering teams.
• Monitor CPPs/CQAs and generate CPV reports for trend analysis.
• Support CAPAs and investigations related to deviations and excursions.
• Assist in technology transfer and development of transfer documentation.

Skills

Process validation

CPV

FDA/ICH guidelines

Statistical analysis

Technical writing

Education

Bachelor's degree

Tools

JMP

Minitab

Job description

Kindeva Drug Delivery is seeking a Process Validation Engineer to lead validation activities across PPQ and CPV, ensuring robust, compliant manufacturing for pharmaceutical and sterile injectable products. You will collaborate with Manufacturing, Quality, Process Development, Engineering, and Regulatory Affairs to drive process performance and lifecycle management.

The role requires 5+ years in pharma manufacturing, strong statistical and technical writing skills, and experience with validation,