Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation. We have an immediate opening in Waunakee, WI (Madison area) for a Validation Specialist to join our growing team.

The Validation Specialist prepares and executes validation protocols for cGMP processes, production/laboratory equipment, cleaning procedures, and software in compliance with Q7. This position is responsible for writing final reports for executed validation protocols and working successfully with other Validation staff on validation protocols.

• Authors and executes qualification/validation protocols.

• Reviews validation and qualification protocols written by other Validation staff members.

• Provides technical assistance to other Validation staff and all other departments regarding validation issues.

• Writes and/or revises department and company SOPs.

• Serves as Validation representative for cross functional projects.

• Participates in external audits (customer, FDA, etc.).

• Bachelor’s degree in Chemistry, Engineering, Statistics, or related discipline required

• A minimum of 2 years of relevant experience with lab and manufacturing equipment required. Knowledge of pharmaceutical manufacturing required. Demonstrated math and technical writing skills required.

• 5+ years of experience preferred. Experience in GMP/GLP/ISO regulated-environment preferred.