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Sr. Validation Engineer

Company: Grand River Aseptic Manufacturing
Location: Grand Rapids
Posted on: March 17, 2023

Job Description:

Quality, Service, Collaboration, Courage

Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture?


Support validation of cGMP equipment, facilities, and processes. This position will focus on process validation, PPQ, and tech transfer. Duties will include but are not limited to validation of laboratory systems, production equipment, manufacturing processes and utilities. Examples of responsibilities include:

  • Write, review, and execute protocols.
  • Write, review, and execute studies for process improvement and scale up projects.
  • Maintains equipment logbooks and other forms to document use, proper cleaning and sterilization.
  • Provide validation support to internal customers such as MSAT, Quality Control, Manufacturing and other users of validation services.
  • Assure that all validation is performed to conform to GRAM's and cGMP requirements.
  • Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
  • Strong attention to detail; Ability to complete tasks with accuracy and efficiency.
  • Ability to interpret and relate Quality and Best Practice Qualification and Validation standards for implementation and review.
    Full job description available during formal interview process.

    REQUIREMENTS: (education)

    Completion of a bachelor's degree in Engineering is required. Related work experience in a pharma, biopharma, and/or biotech manufacturing environment is preferred. Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations is preferred. Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

    What sets GRAM apart from other employers:

    BENEFITS Starting day 1! Blue Cross/Blue Shield medical and dental with the company paying for 75% of the cost is available to you and your family on your first day of work. We also offer vision, life, disability, a 401(k) program, and off-shift premiums.

    Paid VOLUNTEERISM Starting day 1! GRAM encourages giving back to your community by offering 16 hours of volunteer time per calendar year.

    PTO! Full-time employees accrue up to 3 weeks of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

    HOLIDAYS: We celebrate diversity by offering 8 paid holidays per calendar year.

    Pay: Depends on Experience

Keywords: Grand River Aseptic Manufacturing, Grand Rapids , Sr. Validation Engineer, Engineering , Grand Rapids, Michigan

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