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Urgent! Validation Engineer x 3 Job Opening In Boston Massachusetts – Now Hiring The Autumn Group

Validation Engineer x 3



Job description





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<1058> 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.




Required Skill Profession

Other General



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    Unlock Your Validation Engineer Potential: Insight & Career Growth Guide


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