Senior Sterile GMP Process Validation Engineer

Katalyst-Healthcares-; Newark (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Process Validation Engineer to support sterile GMP pharmaceutical manufacturing. The role focuses on process validation, technology transfer, and qualification activities for PFS lines, with emphasis on aseptic processing and PPQ execution in Newark, NJ.

You will collaborate with Manufacturing, Quality, Validation and Engineering teams to prepare protocols and reports, ensure cGMP compliance, and drive continuous improvement through

Qualifications

• 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.

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, ensuring seamless implementation across production lines.
• Coordinate 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.

Skills

Process Validation

Technology Transfer

PPQ execution

Aseptic manufacturing

Media fills

cGMP compliance

FDA regulations

Technical writing

Cross-functional collaboration

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.