Targeting Validation Engineer
1 day ago
BEPC Inc. - Business Excellence Professional Consulting is seeking a highly skilled Targeting Validation Engineer I to join our team in Hillsboro, OR.
Job Summary:
The Targeting Validation Engineer I will be responsible for supporting validation activities and validation change management system for validated equipment, utilities, and facilities. This includes developing, executing, and managing timelines for CA/SIA/RTM/DIA/URS activities, tracking and trending activities, and reporting on issues.
Key Responsibilities:
- Support the development and execution of validation protocols and procedures.
- Coordinate the collection, testing, and analysis of samples and reporting of results.
- 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.
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.
About BEPC Inc. - Business Excellence Professional Consulting:
BEPC Inc. - Business Excellence Professional Consulting is a fast-growing team of consultants dedicated to providing exceptional services to our clients. We offer a dynamic work environment, competitive pay, and opportunities for growth and development.
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Targeting Validation Engineer I
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Targeting Validation Engineer I
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