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Quality Engineer - Validation

Company: Allergan
Location: Waco
Posted on: November 11, 2019

Job Description:

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview
The Quality Engineer, Validation, supports the Quality Laboratories with the qualification cycle of equipment and computer systems.
Main Areas of Responsibilities

  • Maintains the validation timeline and status for validation projects.
  • Manages the activities of validation consultants utilized to assist in the implementations.
  • Develops and communicates project timeline and status.
  • Develops and reviews validation documents and implementation documentation that supports required validation activities. Documents include Validation Project Plan, Requirements and specifications, vendor Evaluation Documentation, Installation/Operational/Performance Protocols and Final Reports.
  • Provides technical assistance, training and work direction to other staff members.
  • Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems or equipment, and assures that protocols are approved through proper channels.
  • Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
  • Interacts with all affected personnel in the execution of protocols and gathering of test data.
  • Ensures that all test data is gathered and recorded in accordance with cGxP requirements and industry trends.
  • Carries out responsibilities in accordance with the organization's policies and procedures, state, federal and local laws.
  • Performs related duties as assigned.
    Requirements
    • Previous experience with Waters LC equipment and Empower, Mettler Toledo equipment and LabX, Lonza MODA, and other QC Chemistry and QC Microbiology equipment is ideal.
    • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), United States (USP) and European (EP) Pharmacopeias, and related federal, state and local laws, codes, regulations and regulatory requirements.
    • Experience with validating QC Laboratory systems.
    • Pharmaceutical quality control processes.
    • Principles and practices of GAMP 5 qualification and validation.
    • Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations.
    • Pharmaceutical principles, practices and applications.
    • Personal computer operations and Microsoft applications (Word, Project, and Excel).
    • Knowledge of management systems and enterprise-type systems.Preferred Skills/Qualifications
      • Relevant experience ? five (5) years preferred.
      • Validation experience ? three (3) years preferred.
      • Intermediate Microsoft Office Skills.
      • Experience with Empower, MODA,LabX, QMS and Trackwise preferred.
      • Experience working in a GMP regulated environment preferred.Education
        • Bachelor's degree in a science, engineering, or related field from an accredited college or university, and three (3) to thirteen (13) years progressively responsible related experience preferably within the food, cosmetic or pharmaceutical industries.

Keywords: Allergan, Waco , Quality Engineer - Validation, Other , Waco, Texas

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