Sterile Process Validation Engineer — PPQ & Tech Transfer

Katalyst CRO; Newark (NJ); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking an experienced Process Validation Engineer for sterile pharmaceutical manufacturing projects in a GMP environment. The role emphasizes process validation, technology transfer, and PPQ execution for PFS lines.

You will collaborate with Manufacturing, Quality, Validation, and Engineering to deliver compliant projects, prepare protocols and reports, and ensure alignment with FDA/cGMP requirements throughout the validation lifecycle.

Qualifications

• Bachelor's degree in engineering, life sciences, or related discipline.
• Experience in process validation in pharma or sterile manufacturing.
• Hands-on technology transfer and PPQ execution experience.
• Strong aseptic manufacturing, media fills, and sterile processing knowledge.
• Excellent writing, communication, and cross-functional collaboration skills.
• Familiarity with FDA regulations, cGMP, and validation lifecycle.

Responsibilities

• Develop and execute process validation strategies for sterile manufacturing processes.
• Lead PPQ activities for pre-filled syringe (PFS) fill lines.
• Support technology transfer projects across production lines.
• Coordinate and evaluate aseptic media fill studies for process verification and compliance.
• Perform process revalidation activities and maintain validated processes.
• Support smoke studies and qualification for automated visual inspection systems.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners.
• Prepare and review validation protocols, reports, risk assessments, and technical documents.
• Ensure compliance with cGMP, FDA regulations, and industry best practices.
• Provide technical support for investigations and process improvements.

Skills

Process validation

PPQ execution

Technology transfer

Aseptic manufacturing

Regulatory compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering or life sciences

Job description

Katalyst CRO is seeking an experienced Process Validation Engineer for sterile pharmaceutical manufacturing projects in a GMP environment. The role emphasizes process validation, technology transfer, and PPQ execution for PFS lines.

You will collaborate with Manufacturing, Quality, Validation, and Engineering to deliver compliant projects, prepare protocols and reports, and ensure alignment with FDA/cGMP requirements throughout the validation lifecycle.