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Validation Specialist / Engineer

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Bachelor's Degree in Science or EngineeringAt least 3 years of relevant experience in the pharmaceutical, medical device, or biotechnology industries. Hands-on experience in process or manufacturing areas. Must be fully bilingual in English and Spanish, with outstanding verbal and technical writing skills. Proficiency with MS Windows and Microsoft Office applications is required. In-depth understanding of cGxP and regulatory guidelines related to compliance, including but not limited to FDA guidelines, cGMP, 820, OSHA, and 21 CFR Part 11.Strong knowledge in Computer System Validation, Kaye Validator, Serialization, Audits, Utilities, Facilities & Equipment Qualification, Process Validation, Product Transfer, Laboratory Equipment, Method Validation, Automation, Lean Manufacturing, and Method Transfer.

About the job

Join our team at Validation Engineering Group, where we are in search of skilled and dedicated professionals who uphold the highest ethical standards and possess expertise in key validation and engineering areas.

As a Validation Specialist / Engineer, your responsibilities will include:

  • Computer System Validation (CSV)
  • Cleaning Validation
  • Validation for Manufacturing, Packaging, and Laboratory Equipment
  • Commissioning and Qualification
  • Quality Engineering for Medical Devices
  • Quality Manufacturing in Medical Devices
  • Process Validation
  • Project Management
  • Quality Control and Assurance

About Validation Engineering Group

Validation Engineering Group (VEG) is a premier service provider delivering innovative solutions across the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device sectors. We specialize in Laboratory Compliance, Computer Engineering, Project Management, Validation, and various other critical services.

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