Pharma Process Validation Engineer I: PPQ & CPV

Kindeva Drug Delivery; Maryland Heights (MO); On-site; USD 110,000 - 150,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Process Validation Engineer to support PPQ, CPV, and technology transfer within our MS&T group. You will collaborate across Manufacturing, Quality, Process Development, and Regulatory Affairs to ensure robust, compliant, and scalable manufacturing processes.

The role emphasizes process validation, data analysis, documentation, and continuous improvement to maintain inspection-ready records and drive process excellence in sterile injectable manufacturing.

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.
• 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 Process Performance Qualification (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.
• Support process risk assessments using tools such as FMEA and process mapping.
• Ensure validation activities are completed in compliance with cGMP requirements and site procedures.
• Monitor and trend CPPs and CQAs; generate CPV reports and identify improvement opportunities.
• Support technology transfer activities for new products and process improvements.

Skills

Technical writing

Analytical skills

Problem solving

Statistical analysis

Education

Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or related technical field

Tools

JMP

Minitab

Job description

Kindeva Drug Delivery is seeking a Process Validation Engineer to support PPQ, CPV, and technology transfer within our MS&T group. You will collaborate across Manufacturing, Quality, Process Development, and Regulatory Affairs to ensure robust, compliant, and scalable manufacturing processes.

The role emphasizes process validation, data analysis, documentation, and continuous improvement to maintain inspection-ready records and drive process excellence in sterile injectable manufacturing.