Validation Engineer

4 days ago

Hillsboro, United States Harvest Technical Services, Inc. Full time
Job Summary

We are seeking a highly skilled Validation Engineer to join our team at Harvest Technical Services, Inc. in Hillsboro, OR.

Main Responsibilities:

  • Support the development, execution, and management of validation activities and change management system for validated equipment, utilities, and facilities.
  • Track and trend activities, reporting on issues that impact predetermined timelines and problems as needed.
  • Coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.
  • Support the change management system for validated equipment, utilities, and facilities.
  • Assist with preparation and review of relevant sections of protocol generations/approvals processes.
  • Serve as a representative on cross-functional and multi-site teams.
  • Support development of formulation, filling, and packaging area SOPs and manufacturing documents as appropriate.

Requirements:

  • BS in chemical, biochemical engineering, or related field/experience, with a minimum of 2 years experience in process engineering, validation engineering, or Technical Services.
  • Strong technical writing skills.
  • Cleaning and Sterilization qualification experience is a must.
  • Experience in the pharma/biotech industry is a plus. Knowledge of cGMPs or equivalent regulations.
  • Working knowledge of formulation, filling, inspection, and packaging equipment qualification in a regulated environment.
  • Demonstrated understanding of project management skills.
  • Ability to work with internal teams, partners, suppliers, and customers.

The hiring range for this position is $39 to $49 per hour. The base pay will be determined based on internal equity, geographic region, job-related knowledge, skills, and experience.

Harvest Technical Services, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

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