Equipment Validation Expert
3 days ago
TalentBurst is searching for an exceptional Equipment Validation Expert to contribute to our team in Hillsboro, OR.
Job Summary:The Equipment Validation Expert will support the development, execution, and management of validation activities and change management systems for validated equipment, utilities, and facilities. This critical role requires a highly skilled professional with a strong background in validation engineering, technical writing, and project management.
Key Responsibilities:- Leading the development, execution, and management of CA/SIA/RTM/DIA/URS activity timelines.
- Tracking and trending activities, reporting on issues impacting predetermined timelines and problems as needed.
- Ensuring validation activities are executed according to established protocols.
- Supporting the change management system for validated equipment, utilities, and facilities.
- Contributing to the development of formulation, filling, and packaging area SOPs and manufacturing documents.
Applicants must meet the following criteria:
- 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.
- Superior technical writing skills.
- Mandatory cleaning and sterilization qualification experience.
- Desirable experience in the pharma/biotech industry, with knowledge of cGMPs or equivalent regulations.
- Familiarity with formulation, filling, inspection, and packaging equipment qualification in a regulated environment.
- Proven project management skills.
- Ability to work collaboratively with internal teams, partners, suppliers, and customers.
- Desirable operational excellence and industrial engineering skills.
- Exceptional written and verbal communication skills.
The estimated annual salary for this position is approximately $90,000-$120,000, contingent upon experience.
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