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Lead Commissioning, Qualification and Validation Support

Company: AM Life Science
Location: Boston
Posted on: February 25, 2021

Job Description:

Lead Commissioning, Qualification and Validation Support Overview Lead Commissioning, Qualification and Validation support of Medical Device Company

  • Provide technical support to site Validation personnel, as well as work with Engineering and QA to ensure reliable and predictable equipment and process operation.
  • In depth understanding of the governing standards for medical device sector.
  • Collaborate with multiple departments including Manufacturing, Facilities, Engineering, Quality Control, Validation, Quality Assurance, and Regulatory to facilitate agreement on equipment and process operational parameters, test requirements and acceptance criteria.
  • Own and Manage Change Controls to allow for the ongoing maintenance and optimization of Validated systems.
  • Generation, execution and closeout of Commissioning and Validation documentation, including test plans, procedures and protocols.
  • Review and approval of a variety of validation lifecycle documents, include but are not limited to validation and/or project plans, user requirement specifications, SOPs, maintenance documentation, investigation reports, deviation resolution, CAPA closeout, etc. Job Requirements
    • BS or MS degree in Science or Engineering
    • 5-10 Years relevant Industry experience
    • Provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing and laboratory process controls.
    • Communicates current and applicable good manufacturing practices (GMP) and to business partners.
    • Executes functions needed to support change control activities and document management requirements.
    • Collaborates with business partners and peers to define validation and change control activity requirements for individual projects.
    • Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on.
    • Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability/reliability.
    • Writes/revises or reviews /approves a variety of validation lifecycle documents. Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports. Key Requirements and Technology Experience
      • A minimum of a Bachelor's degree in Chemical or Mechanical Engineering, Chemistry, Biochemistry, and/or related discipline is required. Master's degree a plus.
      • A strong background in medical device validation is required.
      • Knowledge of current and applicable GMP regulations is required. Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required.
      • Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.
      • Must be analytical, detail-oriented and able to interact with individuals of all levels. Job Application - Project Engineer
        • Name * First Last
          • Address * Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country
            • Phone *
            • Email *
            • How did you hear about AM Life Science?
            • Are you willing to relocate? *
            • Are you willing to travel?
            • Are you authorized to work in the United States? Choose File No File Chosen
              • Upload Resume * Choose File No File Chosen
                • Upload Additional Files Requested Drop files here or
                  • Additonal Information or Relevent Qualifications AM Life Science--- GLOBAL HEADQUARTERS - www.amlifescience.com
                    2213 RR 620 N, Suite 105, Austin, TX 78734 - Phone: (888) 729-1548 - Fax: (512) 266-7783

Keywords: AM Life Science, Boston , Lead Commissioning, Qualification and Validation Support, Other , Boston, Massachusetts

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