Analytical Validation Engineer

Zp Group Llc
  • Philadelphia, PA
    22 days ago

    Job Description

    Responsibilities: Support laboratory commissioning and decommissioning activities within a pharmaceutical GMP environment. Support laboratory instrument selection, installation, qualification, commissioning, and decommissioning. Execute and support IQ/OQ/PQ activities for laboratory instruments and equipment. Provide technical support throughout the laboratory equipment lifecycle. Support laboratory investigations from initiation through completion. Participate in root cause investigations and identify appropriate corrective and preventive actions. Develop and implement CAPAs resulting from laboratory investigations. Author and complete final investigation documentation. Support multiple laboratory projects and activities simultaneously. Collaborate with laboratory, quality, engineering, and other cross-functional stakeholders to resolve technical issues. Apply analytical and critical-thinking skills to identify solutions to laboratory and equipment-related challenges. Maintain compliance with applicable GMP requirements and established procedures. Qualifications: Bachelor's degree in Chemistry, Biology, Biochemistry, or a related scientific discipline . 5+ years of experience working in a GMP pharmaceutical environment . Experience with pharmaceutical laboratory operations. Hands-on experience with laboratory instrument selection, installation, qualification, commissioning, and decommissioning. Experience supporting IQ/OQ/PQ activities. Experience supporting laboratory investigations from beginning to end, including: Root cause identification CAPA implementation Final investigation report authoring Hands-on experience with GMP laboratory instruments, such as: HPLC, particularly Waters AA Autotitrators NIR ICP FT-IR Particle counters Gas analyzers Ability to manage multiple projects and priorities simultaneously and independently. Strong analytical, problem-solving, and critical-thinking skills. Strong interpersonal and communication skills with the ability to collaborate effectively within a team environment. Self-starter with the ability to develop practical and innovative solutions to technical challenges. Demonstrated flexibility and ability to work effectively with cross-functional teams.

    Numbers & Facts

    LocationPhiladelphia, PA

    Skills

    • Analysis Skillsunmatched
    • Biochemistryunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Chemistryunmatched
    • Commissioningunmatched
    • Communication Skillsunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • High Performance Liquid Chromatography (HPLC)unmatched
    • ICPunmatched
    • IR (Infrared)unmatched
    • Interpersonal Skillsunmatched
    • Investigative Reportsunmatched
    • Laboratoryunmatched
    • Laboratory Equipmentunmatched
    • Laboratory Operationsunmatched
    • Multitaskingunmatched
    • Problem Solving Skillsunmatched
    • Process Validationunmatched
    • Project/Program Managementunmatched
    • Quality Engineeringunmatched
    • Root Cause Analysisunmatched
    • Support Documentationunmatched
    • Team Playerunmatched
    • Technical Supportunmatched
    • Writing Skillsunmatched

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