JOB SUMMARY
Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Validation Specialist.
This position is responsible for preparing and executing 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 include:
• Provides technical assistance to other Validation staff and all other departments regarding validation issues.
• Writes and/or revises department and company SOPs.
• Writes and/or reviews validation and qualification protocols (including specification documents, impact assessments, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Process Validations, and Cleaning Validations).
• Serves as Validation representative for cross functional projects.
• Completes qualification/validation protocols (including final reports).
• Participates in external audits (customer, FDA, etc.).
Job Requirements and Qualifications:
Position will be filled up to the Senior level and determined at discretion of the hiring manager. (for “up to” positions)
Associate
Experience: Required- None, Preferred- 2+ years
Education: Required- High School Diploma or G.E.D., Preferred- Bachelor's Degree or above B.S. in Chemistry, Biological Sciences or Engineering (Chemical, Electrical, Mechanical, Reliability) or related discipline
Specialist
Experience: Required- 2+ years, Preferred- 5+ years
Education: Required- High School Diploma or G.E.D., Preferred-
Bachelor's Degree or above B.S. in Chemistry, Biological Sciences or Engineering (Chemical, Electrical, Mechanical, Reliability) or related discipline
Senior
Experience: Required- 5+ years, Preferred- 10+ years
Education: Required- High School Diploma or G.E.D., Preferred- Bachelor's Degree or above B.S. in Chemistry, Biological Sciences or Engineering (Chemical, Electrical, Mechanical, Reliability) or related discipline
WHY JOIN SPL?
Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!
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.