Sterile Process Validation Engineer – PPQ & Tech Transfer

Creative Solutions Services, LLC; Harrisburg (Dauphin County); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Process Validation Engineer to support sterile GMP projects involving pre-filled syringe lines. You will lead validation strategies, PPQ execution, technology transfer, and cross-functional collaboration to ensure regulatory compliance.

The role emphasizes aseptic processing, media fills, and documentation quality, with a focus on continuous improvement and strong writing skills to support regulatory filings.

Qualifications

• Bachelor's degree in engineering, life sciences, or related discipline.
• Experience in Process Validation within pharmaceutical sterile manufacturing.
• Hands-on experience with Technology Transfer and PPQ execution.
• Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
• Familiarity with FDA regulations and cGMP lifecycle requirements.

Responsibilities

• Develop and execute process validation strategies for new and existing sterile manufacturing processes.
• Lead PPQ activities for pre-filled syringe fill lines.
• Support technology transfer projects and implement manufacturing processes across lines.
• Coordinate and evaluate aseptic media fill studies for process performance.
• Perform process revalidation and maintain validated processes.
• Support smoke studies and qualification activities for automated visual inspection systems.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners.
• Prepare and review validation protocols, reports, risk assessments, and technical docs.
• Ensure compliance with cGMP and FDA regulations throughout projects.
• Provide technical support for investigations and continuous improvement initiatives.

Skills

Process Validation

Technology Transfer

PPQ execution

Aseptic Processing

Cross-functional Collab

Media Fills

FDA Regulations

cGMP

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Creative Solutions Services, LLC is seeking an experienced Process Validation Engineer to support sterile GMP projects involving pre-filled syringe lines. You will lead validation strategies, PPQ execution, technology transfer, and cross-functional collaboration to ensure regulatory compliance.

The role emphasizes aseptic processing, media fills, and documentation quality, with a focus on continuous improvement and strong writing skills to support regulatory filings.