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Validation Specialist

Scientific Protein Laboratories Madison, WI

  • Expired: over a month ago. Applications are no longer accepted.
Job 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.

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.

 

Essential Responsibilities

• 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.).

Qualifications

• 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.

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

EOE

Company Description
World Leader in Heparin and Pancreatic Enzymes
Scientific Protein Laboratories (SPL) has been a leading global supplier of high quality active pharmaceutical ingredients (APIs) for over three decades. We specialize in cGMP biopharmaceutical manufacturing and are among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. We serve the pharmaceutical, veterinary, and food industries globally. Our manufacturing facility is located in Waunakee, Wisconsin.

Biopharmaceutical Development and Manufacturing Services
Beyond supplying high quality proprietary APIs, we provide contract process development & cGMP manufacturing services, including heparin derivatives, natural products extraction, fermentation and purification. Within the still-young biopharmaceutical industry, we are among a small group of companies with an established track record in efficient process development, analytical testing, quality assurance, and regulatory support required to provide our customers with cGMP compliant APIs at all phases of clinical development, straight through to commercial launch.

Scientific Protein Laboratories

Why Work Here?
SPL offers a competitive compensation, a comprehensive benefits package and a pleasant work environment.

World Leader in Heparin and Pancreatic Enzymes Scientific Protein Laboratories (SPL) has been a leading global supplier of high quality active pharmaceutical ingredients (APIs) for over three decades. We specialize in cGMP biopharmaceutical manufacturing and are among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. We serve the pharmaceutical, veterinary, and food industries globally. Our manufacturing facility is located in Waunakee, Wisconsin. Biopharmaceutical Development and Manufacturing Services Beyond supplying high quality proprietary APIs, we provide contract process development & cGMP manufacturing services, including heparin derivatives, natural products extraction, fermentation and purification. Within the still-young biopharmaceutical industry, we are among a small group of companies with an established track record in efficient process development, analytical testing, quality assurance, and regulatory support required to provide our customers with cGMP compliant APIs at all phases of clinical development, straight through to commercial launch.

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Madison, WI
USA

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