Validation Specialist

5 hours ago

Hillsboro OR, United States Harvest Technical Services, Inc. Full time
Main Responsibilities:

As a Validation Engineer at Harvest Technical Services, Inc., you will be accountable for supporting validation activities and the validation change management system for validated equipment, utilities, and facilities. Your key responsibilities will include:

Developing, executing, and managing timelines for the execution of Critical Assessment (CA), System Impact Assessment (SIA), Requirements Trace Matrix (RTM), Data Integrity Assessment (DIA), User Requirements (URS), and protocol generations relevant to validation activities.

Tracking and trending activities, reporting on issues such as impact to predetermined timelines and problems as needed.

Supporting validation activities, coordinating the collection, testing, and analysis of samples, and reporting of results required per validation protocol.

Assisting with the change management system for validated equipment, utilities, and facilities.

Preparing and reviewing 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:

To be successful in this role, you will need:

A BS in chemical, biochemical engineering, or a related field/experience, with a minimum of 2 years of 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 is required.

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.

Compensation:

The hiring range for this position is $39 to $49 per hour. The base pay will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

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