Validation Manager

1 day ago


Grand Rapids, Michigan, United States Grand River Aseptic Manufacturing Full time
Job Title: Validation Supervisor

Grand River Aseptic Manufacturing (GRAM) is seeking a highly skilled Validation Supervisor to lead and coordinate qualification and validation activities at our facility.

Key Responsibilities:
  • Maintain and provide oversight of the execution for programs covering equipment and processes related to sterility assurance.
  • Utilize risk assessment to identify critical areas for validation and determine testing approach.
  • Review change control documents, work orders, and document change requests to assess impact on validated systems.
  • Lead validation projects of broad scope and provide direction for contractors and validation staff supporting those projects.
  • Work cross functionally to establish project schedules.
  • Manage resolution of protocol deviations and non-conformances related to Validation projects.
  • Train Validation staff.
  • Ensure that reports meet department and company metrics.
  • Proactively and regularly communicate with the project team to update on validation status.
  • Identify process improvement opportunities and equipment needs for manufacturing and finishing operations.
  • Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
  • Demonstrate superior project management skills and leadership qualities.
  • Support sterility assurance specific deviation investigations and implement CAPA based on validation changes.
Requirements:
  • Completion of a bachelor's degree in Life Sciences or related field.
  • A minimum of 8 years' related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
  • Demonstrated project management and leadership skills.
  • Knowledge of relevant PDA guidance and ISPE Baseline Guides for Commissioning and Qualification.
  • Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
  • Must have proficient computer skills in Microsoft Word, Excel and Outlook.
What We Offer:
  • Medical benefits starting day 1.
  • Paid volunteerism starting day 1.
  • PTO.
  • Wellness time off.
  • Paid holidays.

GRAM is an equal opportunity employer and welcomes applications from diverse candidates. If you meet the required criteria, we encourage you to apply today.


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