Sterile Process Validation Engineer PPQ & Tech Transfer

Katalyst-Healthcares-; New Haven (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. The role focuses on process validation, technology transfer, and qualification activities for pre-filled syringe lines.

The ideal candidate will have hands-on experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance.

Qualifications

• Experience in process validation within a pharmaceutical or sterile manufacturing environment.
• Hands-on experience with Technology Transfer and PPQ execution.
• Strong knowledge of FDA regulations, cGMP, and validation lifecycle requirements.

Responsibilities

• Develop and execute process validation strategies for sterile manufacturing processes.
• Lead PPQ activities for pre-filled syringe (PFS) fill lines.
• Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
• Prepare and review validation protocols, reports, risk assessments, and technical documentation.
• Ensure compliance with cGMP and FDA regulations.

Skills

Process Validation

Technology Transfer

Aseptic Processing

Cross-functional Collaboration

Education

Bachelor's degree in Engineering/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.