Quality Assurance Validation Engineer

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Located in Bend, OR

Salary: 90000-150000

Quality Assurance Validation Engineer – Bend, Oregon

One of Bend’s fastest growing pharmaceutical companies is seeking an experienced Quality Assurance Validation Engineer to join their team!

 

Where You Get to Live!

Bend, Oregon is the mountain town that has it all! Located in the shadows of the Cascade Mountains and surrounded by numerous lakes and rivers, Central Oregon is an outdoor enthusiast’s paradise. Check out the sights and sounds of Bend at: https://vimeo.com/200038114.

 

What You Get to Do!

The Quality Assurance Validation Engineer support validation activities of Quality Control and Operations instrumentation within GMP manufacturing. In this role you will be responsible for maintaining the validated state of the instruments, including analytical and microbiological, from implementation through their full lifecycle.

·         Review internal and external validation protocols and technical report for validation/qualification of facility, equipment, and systems

·         Perform validation document Gap Analysis for equipment with QC and Manufacturing Operations and support the implementation of remediation plans  

·         Lead implementation of validation program, review SOPs and make recommendation as needed 

·         Collaborate with cross-functional teams to ensure that validation approach meet regulatory and industry requirements 

·         Investigate and resolve validation-related issues  

·         Seek education and remain informed on current industry trends, regulations, and best practices 

·         Review and approve equipment calibration and maintenance documents  

·         Provide QA/QV support for continuous improvement projects, including data integrity initiatives within the laboratory and manufacturing environment.  

·         Work with Manufacturing Operations, Quality, in-house technical groups, and other site/networks as required to assist with establishing validation plans, validation strategy, specifications, and qualification protocols 

·         Perform Impact / Risk Assessments

·         Provide QA/QV support in the implementation of change controls and commitment action items 

·         Participate in audit and inspection readiness activities

·         Perform all other related duties as assigned  

 

What You Will Bring:

·         Broad knowledge FDA and international regulations related to GMPs and Pharmaceuticals 

·         Knowledge on regulatory expectations and industry practices for validation using Product Lifecycle approach 

·         Effective written, oral, and interpersonal communication skills

·         Technical writing skills to effectively develop procedures, discrepancies, change controls and associated documents needed to support the validation effort

·         Experience organizing and managing responsibilities while working independently with minimal oversight 

·         Time and project management skills with the ability to multi-task and meet deadlines 

·         Strong time-management skills and the ability to organize and coordinate multiple projects at once

·         Proficiency in enterprise systems, Microsoft Office and other office productivity tools with aptitude to learn new software and systems

·         Bachelor’s degree in a scientific discipline or another discipline with equivalent experience and training

·         5+ years of QA/QV experience developing and executing equipment qualification, process, cleaning, computerized systems validation projects in a Quality Assurance or Technical Services capacity 

·         Strong background and knowledge of EU & US Health authority requirements on equipment, systems, facilities qualification for both API and finished pharmaceutical products 

·         Knowledge of cGMPs and Global Regulatory (E.g., FDA / MHRA / EMEA) guidelines acquired through education, experience, and training

 

To Apply:  For confidential consideration please submit resume to madeline.ball@expresspros.com 

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