Process Validation Engineer

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

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.