Validation Engineering Professional

1 week ago


Hillsboro, United States TalentBurst Full time
Job Title: Validation Engineering Professional

TalentBurst invites applications from experienced Validation Engineering Professionals to fill a key role in our Hillsboro, OR office.

Job Overview:

The Validation Engineering Professional will support validation activities and change management systems for validated equipment, utilities, and facilities. The ideal candidate will have strong technical skills, excellent communication abilities, and the capacity to work effectively in a team environment.

Key Responsibilities:
  • Developing, executing, and managing timelines for CA/SIA/RTM/DIA/URS activities.
  • Tracking and trending activities, reporting on issues affecting predetermined timelines and problems as needed.
  • SUPPORTING VALIDATION ACTIVITIES AND COORDINATING THE COLLECTION, TESTING, AND ANALYSIS OF SAMPLES AND REPORTING RESULTS REQUIRED PER VALIDATION PROTOCOL.
  • Supporting the change management system for validated equipment, utilities, and facilities.
  • Assisting with preparation and review of relevant sections of protocol generations/approvals processes.
  • Serving as a representative on cross-functional and multi-site teams.
  • Supporting the development of formulation, filling, and packaging area SOPs and manufacturing documents as appropriate.
Requirements:

Applicants should possess:

  • A BS in chemical, biochemical engineering, or a related field/experience, with a minimum of 2 years experience in process engineering, validation engineering, or Technical Services.
  • Excellent technical writing skills.
  • Compulsory cleaning and sterilization qualification experience.
  • Prior experience in the pharma/biotech industry is advantageous, along with knowledge of cGMPs or equivalent regulations.
  • Familiarity with formulation, filling, inspection, and packaging equipment qualification in a regulated environment.
  • Proven project management skills.
  • Capacity to work effectively with internal teams, partners, suppliers, and customers.
  • Desirable operational excellence and industrial engineering skills.
  • High-level written and verbal communication skills.

The estimated annual salary for this position is approximately $85,000-$115,000, contingent upon experience.



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