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Validation Engineer x 3
Validation Engineer x 3The Autumn Group LLC • Boston, MA, United States
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Validation Engineer x 3

Validation Engineer x 3

The Autumn Group LLC • Boston, MA, United States
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POSITION SUMMARY :

The Validation Engineer will report to the VCGT Validation leadership or an appropriate designee to execute Commissioning, Qualification and Validation activities

KEY RESPONSIBILITIES :

  • Draft and implement Quality System documentation designed to establish good validation practices within the organization.
  • Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
  • Support all stages of qualification of Analytical Instrument and Manufacturing equipment.
  • Support all stages of qualification of automated manufacturing equipment
  • Conduct Analytical Instrumentation Qualifications in accordance with USP

and Vertex SOPs.

  • Conduct Automation Assessments to ensure compliance with 21 CFR Part 11.
  • Coordinate with vendor personnel to schedule and execute of test plans, if required.
  • Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required.
  • Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality.
  • Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (Client), process performance qualification, material qualifications, etc.
  • Develop cycles for sterilization processes and validate them, if required.
  • Completes assigned training and ensures that they are 100% compliant 100% of the time .
  • Ensure that all Validation activities align with the current SOPs, global standards and cGMP guidelines.
  • Supports right-the-first time culture for all documents distributed across the organization. Ensure the VCGT Validation team reputation and partnership is flourished with the cross-functional teams.

    • IDEAL CANDIDATES :

  • Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment.
  • Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas.
  • Receptive to change - Adapts (quickly) to changing circumstances.
  • Flexibility for off-shift hours, including weekend and night shift work.
  • B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience.
  • Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.
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    Validation Engineer • Boston, MA, United States

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