Principal Quality Engineer

Company: Cryoport Systems, Inc.
Location: Irvine
Posted on: March 18, 2023

Job Description:

Principal Quality Engineer Position Transport to a fulfilling career at Cryoport Principal Quality Engineer - Irvine, CA If you're interested in joining our team, please send your resume and cover letter to - careers@cryoport.com . -Make sure to include the job title of the position you are interested in the subject line of your email. -

Job Title: Principal Quality Engineer
Job Category: Staff FLSA Status: -Exempt
Salary Range: $100,000-$135,000
Position Summary

Responsible for supporting all validation/qualification activities including new and existing products, process validation, and equipment qualification. Ensures Calibration Program operates in compliance with current specifications and requirements to ensure the production of quality products. Supports investigations and change control programs as a subject matter expert. Role and Responsibilities

• Manage the validation process including:
  • Assist in the development of internal validation standards and procedures.
  • Perform internal validations for equipment, new products, and facilities including developing validation protocols and reports, preparing equipment, and documenting test results.
  • Manage validation activities for consulting-related projects for product and lane validations.
  • Coordinate validation activities with appropriate department stakeholders and train staff on requirements and procedures.
  • Develop a master validation plan and track validation activities.
  • Manage testing and product-related equipment including:
    • Create purchasing specifications for testing and calibration of equipment
    • Oversee the equipment calibration program including scheduling and tracking calibration requirements, evaluating calibration results, developing calibration procedures and managing communication with external calibration vendors
    • Provide budget requirements and monitor expenses to budget
    • Support the New Product Development Process including:
      • -Perform FMEA risk assessment and determine risk mitigation strategies.
      • Assist in the development of process-related documentation
      • Support Supplier Evaluation and Monitoring program
        • Assist with the selection of suppliers by performing on-site technical audits
        • Evaluate supplier product and process information to determine approval status
        • Evaluate change control requests for the potential for revalidation requirements.
        • Provide technical support during non-conforming material, customer complaints, and deviation investigations and assist in the determination of appropriate CAPA.
          • Keep current with industry standards and regulatory guidelines Competencies
            • Ability to problem solve and find creative solutions to complex engineering problems.
            • Proficient math, statistics, and data analysis skills including familiarity with Microsoft Office applications, EDMS, and calibration management tools.
            • Demonstrates strong attention to detail and analytical thinking.
            • Ability to manage multiple projects within overlapping timeframes. Qualifications and Education Requirements -
              • Educational background - B.S. in Engineering, Packaging, or a related scientific field.
              • Experience background - 5 or more years of experience in the pharmaceutical, biotech, or medical device industry and/or relevant experience in packaging design, heat transfer, and cryogenics with knowledge of:
                • Equipment and Process Validation using IQ, OQ, and PQ.
                • Familiarity with FMEA, DOE, DMAIC, 5S, Lean Manufacturing, Design for Manufacturing (DFM) / Design for Assembly (DFA) tools and methods.
                • Cleaning validation, cGMP and FDA validation methodology is desirable. Preferred Skills
                  • Understanding of:
                    • Cold Chain logistics,
                    • (GDP) Good Distribution Practices,
                    • USP 36 (Chapter 1079) Good Storage and Distribution Practices for Drug Products,
                    • 21CFR Part 210 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs,
                    • 21CFR Part 211 cGMP for Finished Pharmaceuticals
                      Cryoport is the Premier provider of Cryogenics Solutions to Cell & Gene Therapy Fight against Cancer. Now Seven Global Cryoport Companies and Publically Traded.
                      
                      Excellent Compensation, First in Class Health Benefits, 100% Mathching 401kPlan and Equity.
                      
                      For immediate consideration, please send your resume to gsorge@cryoport.com . -
                      Cryoport - is a trademark of Cryoport, Inc. and used with permission by Cryoport Systems, LLC

Keywords: Cryoport Systems, Inc., Irvine , Principal Quality Engineer, Engineering , Irvine, California