PharmEng Technology

Senior Validation Engineer

PharmEng Technology Duluth, GA
PharmEng Technology

Senior Validation Engineer

PharmEng Technology Duluth, GA
2 days ago 73 applicants

See who PharmEng Technology has hired for this role

We are seeking an experienced Senior Validation Engineer. Our ideal candidate is a versatile engineering professional, with superior skills and experience in the optimization of procedure improvement and a willingness to work in a dynamic, on-site pharmaceutical project environment.

Job Responsibilities

  • Develop and execute validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment.
  • Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
  • Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
  • Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
  • Responsible for vision systems equipment specification development.
  • Provide input to user requirements, design specifications, process parameters, and FMEA assessments.
  • Independently execute, and direct others in the execution of, the design of processes and equipment by applying novel engineering concepts and techniques within the discipline.
  • Identify new technologies for vision equipment, including implementation of AI. Design and conduct testing to evaluate these new technologies and equipment changes as part of the technical roadmap.

Job Requirements

  • A bachelor’s degree in computer, electrical, mechanical, or related Engineering Area.
  • Minimum of 10 years relevant experience as a Process Engineer.
  • Minimum 10 years of experience working in a GMP environment.
  • Need Reactors and Bioreactors experience.
  • A technical and regulatory background in vision systems in the pharmaceutical industry.
  • Experience in large capital/expansion programs with direct design responsibility.

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Pharmaceutical Manufacturing

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