KH
Process Validation Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
1 month ago
- GMP
- Regulatory Compliance
- Technical Writing
1 month ago
- 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.
- 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.
- 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.
Process Validation Engineer · Katalyst Healthcares & Life Sciences