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    Validation Specialist

    Catalent
    1-6 years
    Not Disclosed
    Princeton Junction
    13 June 3, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

     

    Job Title: Validation Specialist

    Summary

    In this critical position, the Validation Specialist is responsible for authoring and executing installation, operation, and performance process and equipment qualifications (IOPQ) for the site to ensure compliance with local and global regulatory agency requirements, internal company standards, and current industry practices.

    Role Responsibilities

    • Validation Protocols: Generate and execute validation protocols (IQ/OQ/PQ) for site equipment, including production equipment, utilities, and other related systems in compliance with applicable regulatory requirements (EU/GMP, etc.).
    • Execution: Perform hands-on execution of Installation, Operational, and Performance Qualifications for equipment, facility, utilities, cleaning, and manufacturing processes in accordance with predefined test protocols.
    • Deviation Management: Resolve deviations and non-conformances reported during validation/qualification.
    • Data Analysis: Analyze validation results and compile data into summary reports for initial qualifications and re-qualifications.
    • Scheduling: Coordinate testing schedules with impacted area managers and quality control based on project needs.
    • SOP Development: Provide input to the technical composition of standard operating procedures, create department SOPs, review and revise as applicable.
    • Investigation: Investigate and resolve validation problems; participate in equipment failure investigations, corrective/preventive actions, and equipment release.
    • Documentation: Author and execute master and completed CQV protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
    • Risk Assessment: Participate in authoring risk assessments, FMEAs, periodic qualifications, project plans, master plans, and annual product reviews.
    • Compliance: Review change control, SOPs, calibration, preventative and corrective maintenance documentation for equipment/systems to assure they remain in a validated state.

    Candidate Requirements

    • Education: Bachelor's degree in engineering, biomedical engineering, or equivalent scientific discipline.
    • Experience: Minimum of five years of related experience in validation in a GMP (Good Manufacturing Practices) environment.
    • Skills:
      • Effective communication (verbal and written).
      • Ability to work independently or in a team environment.
      • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Access).
      • Strong organizational skills and ability to manage multiple projects simultaneously.
      • Experience in analyzing, reporting, and documenting information with attention to detail.
      • Ability to meet deadlines under pressure.

    Position Benefits

    • Paid Time Off: 152 hours PTO & 8 holidays.
    • Healthcare: Medical, dental, and vision benefits.
    • Retirement: 401k plan.
    • Education: Tuition reimbursement.

    Company Overview

    Catalent is a global drug development and delivery leader, producing over 70 billion doses per year. Catalent collaborates with pharma, biopharma, and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. We are committed to the health and safety of our employees, visitors, and the customers and patients we serve.

    Equal Opportunity Employer

    Catalent is an Equal Opportunity Employer, including disability and veterans. We are committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Catalent maintains a drug-free workplace.

    Application Instructions

    Visit Catalent Careers to explore career opportunities. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email and confirming your request for an accommodation. Include the job number, title, and location to DisabilityAccommodations@catalent.com.

    Security Notice

    Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number, or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, do not respond and forward such requests to spam@catalent.com for investigation.

    Contact Information

    For more information or to apply, please visit Catalent Careers.

     

     

     

     

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