Process Validation Engineer I: PPQ, CPV & Tech Transfer

Kindeva; Maryland Heights (MO); On-site; USD 110,000 - 160,000; Full time

Job summary

Kindeva is seeking a Process Validation Engineer to support PPQ, CPV, and technology transfer within our MS&T organization. You will partner with Manufacturing, Quality, Process Development, Engineering, and Regulatory Affairs to ensure robust, compliant processes for sterile injectable products.

The role emphasizes validation strategy, data analysis, and continuous improvement while adhering to cGMP and regulatory expectations across FDA/ICH guidelines.

Qualifications

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or related technical field.
• 5+ years of experience in pharmaceutical, biopharmaceutical, or sterile injectable manufacturing.
• Experience with process validation, PPQ execution, CPV, technology transfer, or manufacturing support activities.
• Working knowledge of cGMP regulations, FDA guidance, and ICH validation principles.
• Strong technical writing, analytical, and problem-solving skills.
• Experience with statistical analysis tools such as JMP, Minitab, or equivalent software.

Responsibilities

• Author and execute PPQ protocols, reports, sampling plans, and validation documentation.
• Coordinate validation activities with Manufacturing, Quality Control, Quality Assurance, and Engineering teams.
• Analyze validation data and perform statistical evaluations to assess process capability and performance.
• Monitor and trend CPPs and CQAs for CPV and identify opportunities for improvement.
• Support technology transfer activities for new products and process improvements.
• Prepare, review, and maintain validation protocols, reports, and supporting documentation.

Skills

Technical writing

Analytical thinking

Problem solving

Cross-functional collaboration

Statistical analysis

Education

Bachelor's degree in Engineering/Pharma

Tools

JMP

Minitab

Job description

Kindeva is seeking a Process Validation Engineer to support PPQ, CPV, and technology transfer within our MS&T organization. You will partner with Manufacturing, Quality, Process Development, Engineering, and Regulatory Affairs to ensure robust, compliant processes for sterile injectable products.

The role emphasizes validation strategy, data analysis, and continuous improvement while adhering to cGMP and regulatory expectations across FDA/ICH guidelines.