Process Validation Engineer

Katalyst CRO; Harrisburg (Dauphin County); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced Process Validation Engineer to support sterile pharmaceutical manufacturing projects, focusing on process validation, technology transfer, and qualification activities for PFS lines. The ideal candidate will have hands-on experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure compliant, timely project delivery.

You will write and review validation protocols and reports, coordinate media fills and smoke studies, and

Qualifications

• Bachelor's degree in engineering, Life Sciences, or related discipline is required.
• Experience in Process Validation within a pharmaceutical or sterile manufacturing environment is required.
• Hands-on experience with Technology Transfer and PPQ execution is required.
• Strong knowledge of aseptic manufacturing, media fills, and sterile processing is essential.
• Experience supporting smoke studies and qualification activities is preferred.
• Excellent technical writing, communication, and cross-functional collaboration skills are essential.
• Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements is expected.

Responsibilities

• Develop and execute process validation strategies for new and existing sterile manufacturing processes.
• Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
• Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
• Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
• Perform process revalidation activities and maintain validated manufacturing processes.
• Support smoke studies and qualification activities for automated visual inspection systems.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
• Prepare and review validation protocols, reports, risk assessments, and technical documentation.
• Ensure compliance with cGMP, FDA regulations, and industry best practices.
• Provide technical support for investigations, process improvements, and continuous improvement initiatives.

Skills

Aseptic processing

Cross-functional collaboration

Technical writing

Communication skills

Education

Bachelor's degree in engineering, Life Sciences, or related

Tools

Technology Transfer

PPQ execution

Job description

We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross‑functional collaboration to ensure successful project delivery and regulatory compliance.

Job Description

• We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross‑functional collaboration to ensure successful project delivery and regulatory compliance.

Responsibilities

• Develop and execute process validation strategies for new and existing sterile manufacturing processes.
• Lead Process Performance Qualification (PPQ) activities for pre‑filled syringe (PFS) fill lines.
• Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
• Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
• Perform process revalidation activities and maintain validated manufacturing processes.
• Support smoke studies and qualification activities for automated visual inspection systems.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
• Prepare and review validation protocols, reports, risk assessments, and technical documentation.
• Ensure compliance with cGMP, FDA regulations, and industry best practices.
• Provide technical support for investigations, process improvements, and continuous improvement initiatives.

Requirements

• Bachelor's degree in engineering, Life Sciences, or a related discipline.
• Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
• Hands‑on experience with Technology Transfer and PPQ execution.
• Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
• Experience supporting smoke studies and qualification activities.
• Excellent technical writing, communication, and cross‑functional collaboration skills.
• Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.