Process Validation Engineer

Katalyst Healthcares and Life Sciences

New Haven, CT

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.

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Vacancy posted 4 days ago

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