Validation Specialist
Job Details
Experienced
Scientific Protein Laboratories - Waunakee, WI
Full Time
4 Year Degree
Day
Science
Description

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.

 

Prepares and executes validation protocols for cGMP processes, production/laboratory equipment, cleaning procedures, and software in compliance with Q7. Writes final reports for executed validation protocols. Assists other Validation staff with their validation protocols.

 

Responsibilities

  • Completes qualification/validation protocols (including final reports).
  • Writes and/or revises department and company SOPs.
  • Reviews validation and qualification protocols (including SLIA/CLIA's) written by other validation staff members.
  • Serves as Validation representative for cross functional projects.
  • Authors SLIA/CLIA documents.
  • Serves as Validation representative for cross functional projects.
  • Provides technical assistance to all other departments regarding validation issues. 
  • Participates in external audits (customer, FDA, etc.).
Qualifications
  • Bachelors degree in Chemistry, Engineering, Statistics or related discipline required.
  • A minimum of 2 years of relevant with lab and manufacturing equipment. 
  • Knowledge of pharmaceutical manufacturing required.  
  • Demonstrated math and technical skills required.
  • 5+ years of experience preferred.  Experience in GMP/GLP/ISO regulated environment preferred.

 

SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment.

 

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

 

 

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