Pharmaceutical Quality Engineer

Pharmaceutical Quality Engineer

Who?

Does Pharmaceutical Quality Engineer sound like your next job title?

This exciting opportunity is offered by Oregon Freeze Dry. We are a World Class, purpose-driven technology solutions company with nearly six decades of freeze-drying expertise. We find inspiration in our ability to create solutions, through the science and craft of lyophilization, that improve the lives of individuals and communities around the globe. Our driven and passionate team needs to expand, as we continue to experience sustainable growth across multiple markets.

What?

As part of the OFD BioPharma Quality Assurance department, the Quality Engineer will play a critical role in ensuring the safety, reliability, and compliance of Biopharma products within the regulated segment of OFD. This role will maintain high standards and uphold quality assurance processes and principles of good manufacturing and related practices (GxPs).

Main aspects of the role include:

Monitor and test the quality of biopharmaceutical products/samples (both raw materials and finished goods) throughout their lifecycle, including stability.

Collaborate with Quality, Manufacturing, Process Development and Engineering Teams in equipment design Installation, Operational, Process Qualification (IQ/OQ/PQ).

Testing & monitoring of environmental conditions to ensure adherence to US & International guidelines.

Management of batch production records throughout the product lifecycle.

Provide QA guidance for Manufacturing, Maintenance, and Engineering including auditing, coaching, and conducting periodic walkthroughs. Ensures regulatory compliance and procedural consistency between program and practices.

Participation and facilitation of QMS Systems, including: Complaint Investigations, Corrective and Preventative Actions, Non-Conforming Material Reports, Change Management, Risk Assessments, Internal Audits and support of client audits

Implement corrective and preventive actions to address quality-related challenges.

Create and maintain quality documentation, including functional quality records, standard operating procedures (SOPs), work instructions, protocols, programs, policies, and reports.

Conduct risk assessments related to product quality, safety, and compliance; develop risk mitigation strategies to prevent quality issues.

You!

The ideal candidate will have a Bachelor’s degree in Engineering, Science or related field is preferred with 3 years active experience in pharmaceutical, medical device or other FDA/ISO regulated industry. This candidate should have in working knowledge of pharma industry regulations and standards, with knowledge of lypohilization or other preservation technologies. The individual should have strong computer skills, with the ability to analyze data, draw conclusions and present results. Additionally, the ability to understand statistical analysis methods and applications is highly desired. This position does require the ability to flex hours depending on business needs.

Curious? Apply with your resume at Careers Oregon Freeze Dry (ofd.com) or you can find more information about our company on our website.

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…