Validation Specialist

2 days ago


Hillsboro OR USA, United States Planet Pharma Full time
Main Purpose of the Position:

The Validation Engineer will be accountable for supporting validation activities and validation change management system for validated equipment, utilities, and facilities at Planet Pharma.

Key Responsibilities:

  • Support the development, execution, and management of timelines for CA/SIA/RTM/DIA/URS activities.
  • Track and trend activities, reporting on issues affecting predetermined timelines and problems as needed.
  • Support validation activities, coordinating 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.
  • Foster an environment that encourages continuous learning, maintaining expertise to stay abreast of technical and industry advancements.

Qualifications / 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 is required.
  • Strong technical writing skills.
  • Cleaning and Sterilization qualification experience is a must.
  • Experience in the pharma/biotech industry is a plus, with 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.
  • Operational excellence and industrial engineering skills are a plus.
  • Professional level written and oral communication skills.

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