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Validation Engineer

Global Channel Management, Inc

Validation Engineer

Raritan, NJ
Full Time
Paid
  • Responsibilities

    Validation Engineer needs 3 to 5 years experience.

    Validation Engineer requires:

    • Ø BA/BS Required, preferred to be in relevant technical discipline.
    • Ø Experience in a cGMP/FDA licensed facility preferred.
    • Ø Experience in one or more of the following areas preferred:
    • Ø Computer/Software/Systems
    • Ø Biomedical Engineering/Mechanical Engineering/Automation
    • Ø Medical Technology/Biology/Chemistry or associated science
    • Ø Experience in Medical Device, Pharmaceuticals, Life Sciences or Laboratory systems processes / projects
    • Ø Must be Quality-minded, detail-oriented and possess excellent writing skills.
    • Ø 3 to 5 years experience.

    Validation Engineer duties:

    • Ø Authors, reviews and/or approves validation documentation including protocols, reports and other sources of information to ensure that validations and procedures are consistent with current industry standards and Regulatory requirements.
    • Ø Authors, executes, and reviews of Validation plans, IOQ and PQ protocols, final reports to support manufacturing operations and equipment, laboratory equipment, and production processes within a strictly regulated facility.
    • Ø Temperature mapping and other activities to support the facility's continuous process verification program.
    • Ø Support changes required for continuous improvement initiatives and change management throughout plant operations.
    • Ø Ensures that validation and qualification activities are consistent with company validation policies and procedures.
    • Ø Demonstrates a basic understanding of the Product Engineering and Quality Management System concepts.
    • Ø Proceeds according to the company's quality policy in all business activities with providers and customers within and outside the company.
    • Ø Exhibits a basic understanding of statistical process controls (SPC),the DMAIC process and other quality and manufacturing investigative tools.
    • Ø Experience in working with cross-functional teams, including technical and non-technical work.
    • Ø Ability to organize and present technical information with minimal assistance.
    • Ø Provides training and guidance on aspects of validations and qualifications.
  • Industry
    Financial Services