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Validation Engineer Jobs in Pennsylvania

Process Validation Engineer

Katalyst Healthcares & Life Sciences
  • Harrisburg, PA
  • Instant Apply
30+ days ago

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.

Numbers & Facts

LocationHarrisburg, PA

Skills

  • Asepsisunmatched
  • Assembly Lineunmatched
  • Best Practicesunmatched
  • Biologyunmatched
  • Continuous Improvementunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Drug Manufacturingunmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing/Industrial Processesunmatched
  • Process Developmentunmatched
  • Process Engineeringunmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Project Executionunmatched
  • Regulatory Complianceunmatched
  • Requirements Validation/Verificationunmatched
  • Risk Analysisunmatched
  • Sales Qualificationunmatched
  • Team Playerunmatched
  • Technical Supportunmatched
  • Technical Writingunmatched
  • Validation Planunmatched
  • Writing Skillsunmatched

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