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Sr. QA Validation Engineer

Company: Tolmar, Inc.
Location: Fort Collins
Posted on: February 22, 2021

Job Description:

This position has the overall responsibility for performing the Quality Assurance review and approval of all aspects for commissioning, qualification, and validation (CQV) of facility, utilities, manufacturing and packaging equipment, cleaning validation, and process validation for Tolmar's product manufacturing sites. The position assures that validation activities associated with remediation, technology transfers, and product launches are supported in a timely manner and in compliance with Tolmar policies and procedures and per the guidance and requirements of the CFR, ISO and international regulations.-- Essential Duties and Responsibilities

  • Provide Subject Matter Expert (SME) support in a fast-paced production environment with high quality and regulatory standards.
  • Provide technical direction for commissioning, qualification and validation activities of aseptic and semi-solid manufacturing to ensure compliance with internal policies and procedures, current industry standards, cGMPs and current regulatory requirements.
  • Support, create, write and update validation guidelines, policies and procedures.
  • Develop and update Validation Master Plans for the manufacturing sites on an as-needed basis.
  • Work with Manufacturing Science and Technology (MS&T), Production, Engineering, Maintenance, and Development departments to assure that all required documentation is appropriately developed to support process, cleaning, facilities, aseptic, filling/packaging.
  • Provide guidance and technical expertise in cycle development initiatives and activities.
  • Provide QA validation support to Dermatology and Aseptic manufacturing, assess impact to product quality and determine appropriate actions.
  • Participate in audits and follow up on corrective actions.
  • Review and approve validation test protocols, test plans, and final reports, ensuring that they are in alignment with regulatory expectations.
  • Conduct and participate in investigative meetings relating to validation manufacturing test failures. Assess impact of production deviations.
  • Maintain up-to-date knowledge of cGMP regulatory issues, particularly pertaining to validation, and ensure that company validation policies and procedures are updated accordingly.
  • Coordinate activities with different cross-functional team members and execute projects to ensure compliance and maintain systems in a validated state in a timely manner.
  • Perform other related duties as assigned. --Knowledge, Skills & Abilities--
    • Ability to work independently with minimal supervision.
    • Organized and able to meet project deadlines.
    • Ability to assist in the development of validation strategies.
    • Thorough knowledge of FDA validation guidelines and industry best practices, cGMPs, ISO, and EU standards for aseptic processing, clean rooms and semi-solids manufacturing.
    • Knowledge and understanding of aseptic and semisolids operations requirements.
    • Ability to work well with employees at all levels.
    • Experience in creating and modifying SOP, protocols, reports, and other GMP supporting documents.
    • Computer literacy in Microsoft Office programs, including Outlook, Word and Excel.
    • Effective troubleshooting and problem solving skills.
    • Ability to clearly communicate (oral and/or written).
    • A valid driver's license and acceptable Motor Vehicle record may be required. Core Values
      • The Sr. QA Validation Engineer is expected to operate within the framework of Tolmar's Core Values:
        • Consistently operate with the highest standards of ethics and compliance.
        • Take ownership of your actions, success and setbacks.
        • Respect each other and understand that honest collaboration is at the heart of our company success.
        • Go the extra mile to make things happen.
        • Be committed to all we do and the patients we serve.
        • Embrace change with enthusiasm.
        • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task. Education & Experience
          • Bachelor's Degree in scientific or engineering discipline required.
          • Eight or more years of experience in the pharmaceutical or biopharmaceutical industry.
          • Six or more years of validation experience, with at least 5 years performing pharmaceutical validation activities.
          • Operational knowledge of process, cleaning, aseptic, semi-solid, and filling/packaging required.
          • Includes general office environment conditions, work may require occasional weekend and/or evening work.
          • Includes occasional work in a manufacturing type of environment, requires gowning to Tolmar Standard Operating Procedure requirements in addition to aseptic (clean room) gowning. Qualifications Education Required Bachelors or better in Chemistry or related field. Bachelors or better in Engineering or related field. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Tolmar, Inc., Fort Collins , Sr. QA Validation Engineer, Engineering , Fort Collins, Colorado

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