On-site Biologics Process Validation Co-op

Radiometer; Fargo (ND); On-site; USD 39,000 - 47,000; Full time

Job summary

Aldevron, a Danaher operating company, is seeking a Process Validation Engineering Co-op to support validation activities across the biologics lifecycle at our Fargo, North Dakota site. This on-site role reports to the Manager, Process Validation and collaborates with MSAT, QA/QC, Engineering, and Regulatory Affairs to deliver validation deliverables.

The role emphasizes data interpretation, Excel-based analysis, and exposure to GMP environments, with opportunities to work on APS, PQ, CCIT, and

Qualifications

• Pursuing a Bachelor's degree in Chemical Engineering, Bioprocess Engineering, Biomedical Engineering, Biological Systems Engineering, Biotechnology, or related STEM field.
• Ability to interpret technical data and apply scientific principles in a regulated environment.
• Proficiency with Excel for data analysis, reporting, and visualization.
• Experience with statistical analysis and data visualization tools (JMP or Minitab) is a plus.

Responsibilities

• Support development, execution, and reporting of process validation activities for biologics manufacturing processes.
• Participate in validation studies including APS, PQ, cleaning validation, hold-time studies, CCIT, and other GMP qualification activities.
• Collaborate with Manufacturing, MSAT, QA/QC, Engineering, and Regulatory Affairs to deliver validation results.

Skills

Data interpretation

Excel

Statistical analysis

Data visualization

Education

Bachelor's degree in Chemical Engineering / Bioprocess Engineering / Biomedical Engineering / Biological Systems Engineering / Biotechnology

Tools

JMP

Minitab

Job description

Aldevron, a Danaher operating company, is seeking a Process Validation Engineering Co-op to support validation activities across the biologics lifecycle at our Fargo, North Dakota site. This on-site role reports to the Manager, Process Validation and collaborates with MSAT, QA/QC, Engineering, and Regulatory Affairs to deliver validation deliverables.

The role emphasizes data interpretation, Excel-based analysis, and exposure to GMP environments, with opportunities to work on APS, PQ, CCIT, and