Validation Engineer jobs in New York

Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Validation Engineer
  • Katalyst Healthcares & Life Sciences
  • Manhattan, NY FULL_TIME
  • Responsibilities:

    Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams.

    Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations. Preparation and review of associated procedures, change controls, standard operating procedures, validation master plans, etc.

    Execute protocols and related activities associated with validating equipment/ systems/ utilities/ processes, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring.

    Initiate and investigate protocol deviations, events, exceptions, and coordinate follow up with QA.

    Initiate, follow-up, close out and implementation of corrective and preventive actions.

    Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related to but not limited to instruments, equipment, products, and processes.

    Coordinate with cross functional teams for internal and external audits. Provide all required documentation.

    Perform other duties as assigned.

    Requirements:

    Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

    Analytical – Working knowledge of cGMPs and internal SOPs; identifies, collects, and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner.

    Technical Skills – Mechanically inclined; reads and interprets process documents and validation protocols; follows operating instructions; and good computer skills; ability to make timely decisions, Assist Manufacturing management/QA management in performing root cause analysis.

    Ability to read, write and interpret documents such as Site Master Plans, Validation Master Plans, Validation protocols, Technology Transfer Documents, Master Production Records, Operating and Maintenance Instructions, and procedures manuals.

    A background in cGMP compliance within the pharmaceutical, biologics, or medical device manufacturing industry

  • 8 Days Ago

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Validation Engineer Staff 2
  • CAI
  • Albany, NY FULL_TIME
  • Position Description:The CQV Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible f...
  • Just Posted

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Validation Engineer Staff 1
  • CAI
  • Albany, NY FULL_TIME
  • Position Description:The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verifi...
  • Just Posted

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Validation Engineer Senior 1
  • CAI
  • Albany, NY FULL_TIME
  • Position Description:The CQV Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible f...
  • 21 Days Ago

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Validation Engineer Senior 2
  • CAI
  • Albany, NY FULL_TIME
  • Position Description:The CQV Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are responsible f...
  • 9 Days Ago

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Junior Engineer; Validation
  • CONTRACT PHARMACAL CORP
  • Hauppauge, NY FULL_TIME
  • DescriptionPosition Summary:The Junior Validation Engineer is responsible for performing qualification and engineering activities for solid dosage pharmaceutical manufacturing and packaging equipment,...
  • 1 Month Ago

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Process/Validation Engineer
  • Katalyst HealthCares and Life Sciences
  • Durham, NC
  • Responsibilities: Validation Planning: Develop and implement validation strategies, including process, equipment, and cl...
  • 4/24/2024 12:00:00 AM

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Process Validation Engineer
  • Novozen Healthcare LLC
  • Project Description: New Filling Lines Contractor Tasks and Responsibilities: Job Description: The client is looking for...
  • 4/23/2024 12:00:00 AM

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QA Process Validation Engineer
  • Mastech Digital
  • Title : QA Process Validation Engineer Location : Worcester MA Duration : 12+ months Job Description : Perform QA on-the...
  • 4/23/2024 12:00:00 AM

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Process Validation Engineer
  • Katalyst Healthcares & Life Sciences
  • Austin, TX
  • Responsibilities:Defines validation strategy and requirements and ensure implementation.Review and approve validation re...
  • 4/23/2024 12:00:00 AM

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Process Validation Engineer (Medical Devices)
  • Katalyst HealthCares and Life Sciences
  • Austin, TX
  • Evaluate validation of the equipment, software and processes used in development and production of medical ! products en...
  • 4/23/2024 12:00:00 AM

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Validation Engineer
  • Sigmaways Inc
  • Chandler, AZ
  • As a validation Engineer, you will be responsible for ensuring that radio power systems meet specified requirements and ...
  • 4/23/2024 12:00:00 AM

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Project Engineer, Validation Engineering
  • Precision for Medicine
  • Alexandria, VA
  • Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry....
  • 4/22/2024 12:00:00 AM

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Project Engineer, Validation Engineering
  • Precision Medicine Group
  • Raleigh, NC
  • Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry....
  • 4/21/2024 12:00:00 AM

New York is a state in the Northeastern United States. New York was one of the original thirteen colonies that formed the United States. New York covers 54,555 square miles (141,300 km2) and ranks as the 27th largest state by size.[3] The highest elevation in New York is Mount Marcy in the Adirondacks, at 5,344 feet (1,629 meters) above sea level; while the state's lowest point is at sea level, on the Atlantic Ocean. In contrast with New York City's urban landscape, the vast majority of the state's geographic area is dominated by meadows, forests, rivers, farms, mountains, and lakes. Most of...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$59,559 to $79,558

Validation Engineer in Muskegon, MI
As the Process Validation Engineer you will perform process validation activities to ensure cGMP requirements are met with regards to the IQ, OQ and PQs.
February 08, 2020
Validation Engineer in Ogden, UT
Knowledge of system validation “life-cycle” concept.
February 17, 2020
Validation Engineer in Baton Rouge, LA
There are validation engineer job opportunities across the entire industry including pharmaceutical, biotechnology and medical devices companies.
December 18, 2019