Process Development Engineer

Location
Albany, Oregon
Salary
Competitive salary based on experience and education
Posted
Jun 20, 2022
Required Education
Bachelors Degree
Position Type
Full time

Oregon Freeze Dry is 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 that improve the lives of individuals and communities around the globe. Our customers and consumers look to us to do this through the science and craft of freeze-drying / lyophilization. Our driven and passionate team needs to expand as we continue to experience strong sustainable growth across multiple markets. 

We are looking for the intellectually curious who want to make a difference in a fast growing, quick paced team environment and who are inspired by the opportunity to pioneer new areas that touch lives all over the world!  Are you that person?

We are seeking a Bio|Pharma Process Development Engineer. We bring an innovative approach to designing and commercializing new product concepts, whether for start-up or Fortune 100 multinational organizations. This position will develop and oversee the analysis of independent process steps and the production process within the laboratory, pilot, and /or engineering batches. It also involves development of the process to focus on designing protocols and generating data based on critical criteria in each specific project.

SPECIFIC DUTIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:

           Planning:

  • Sets goals to achieve strategy and annual plan objectives. Supports Sales & Bio|Pharma by providing expertise and collaboration in development of new project scope of work, protocol development, execution, reporting, and deliverables for internal and customer evaluation, and assist with risk analysis for new project evaluation.

           R&D:

  • Formulation chemistry, experimental design, analysis, and reporting on individual and collaborative development projects per annual plan. Identifying equipment selection, procurement, documentation (SOP, MP, etc.), validation/qualification, calibration, and as necessary, validation for specific uses.

           Quality/Compliance:

  • Maintain custody of SOP’s, Mtc MP’s, calibration CP’s, master batch records, trend analysis (processes, environment, purified water system), deviation Investigation, and CAPA. Approval of all specifications.

           Manufacturing:

  • Material movement for campaign; Monitor GMP activities and measures; Change control (CCR’s). General GMP and SOP training of operators per product responsibility.

QUALIFICATIONS

  • Bachelor in Chemistry, Engineering, or Science related degree or closely related fields.
  • Knowledge of lyophilization, formulation chemistry and process scale-up.
  • General knowledge of Lean Six Sigma concepts.
  • Understanding of statistical analysis methods and applications.
  • Demonstrated strong computer skills including proficiency in Microsoft Office applications.
  • Demonstrated independent ability to analyze data, draw conclusions, and present results.
  • Demonstrated experience working with cross-functional teams on projects impacting multiple departments.
  • Demonstrated good verbal and written communication skills through positive and effective information sharing.
  • Must hold current, valid drivers’ license, provide proof of current automobile insurance and have reliable transportation. 

SALARY

Competitive salary based on experience and education. Excellent benefits package including medical, dental, vision, paid time off, paid holidays, and more!