Validation Engineer I-Cleaning and Sterilization
2 days ago
About the Role:
BEPC Inc. - Business Excellence Professional Consulting is seeking a highly skilled Validation Engineer I-Cleaning and Sterilization to join our team in Hillsboro, OR. As a key member of our team, you will be responsible for supporting validation activities and validation change management system for validated equipment, utilities, and facilities.
Key Responsibilities:
- Develop, execute, and manage 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.
- Represent the company on cross-functional and multi-site teams.
- Support development of formulation, filling, and packaging area SOPs and manufacturing documents as appropriate.
- Foster a culture of continuous learning, maintaining expertise to stay abreast of technical and industry advancements.
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, 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.
About BEPC Inc. - Business Excellence Professional Consulting:
BEPC Inc. - Business Excellence Professional Consulting is a fast-growing company that provides consulting services to the pharma/biotech industry. We are committed to excellence and innovation, and we are seeking talented individuals to join our team.
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hillsboro, United States BEPC Inc. - Business Excellence Professional Consulting Full timeJob Title: Validation Engineer I-Cleaning and SterilizationAbout the Role:BEPC Inc. - Business Excellence Professional Consulting is seeking a highly skilled Validation Engineer I-Cleaning and Sterilization to join our team in Hillsboro, OR.Job Summary:The successful candidate will be responsible for supporting validation activities and validation change...
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Hillsboro, United States BEPC Inc. - Business Excellence Professional Consulting Full timeBEPC is looking for a Validation Engineer I-Cleaning and Sterilization in Hillsboro, OR to join our fast-growing team of consultants!W2 Contract: 10 months with opportunities for extensions based on business needs and performance.Pay Range: $44.27- 48.27/hr. plus we offer Medical, Dental, Vision and Life Insurance benefits!Schedule: 100% Onsite in...
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hillsboro, United States BEPC Inc. - Business Excellence Professional Consulting Full timeBEPC is looking for a Validation Engineer I-Cleaning and Sterilization in Hillsboro, OR to join our fast-growing team of consultants!W2 Contract: 10 months with opportunities for extensions based on business needs and performance.Pay Range: $44.27- 48.27/hr. plus we offer Medical, Dental, Vision and Life Insurance benefits!Schedule: 100% Onsite in...
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