Validation Specialist

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 company with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL has specialized in the development and cGMP-compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity for a Validation Specialist.

In the Validation Specialist position, you will partner with Engineering, Operations, Quality, Scientific Affairs, Maintenance, Metrology, Quality Control, and vendors, delivering and executing qualification requirements in a regulated environment.

You will follow standard operating procedures and exercise your judgment to determine the appropriate actions for completing qualification and validation activities at SPL.

Key Responsibilities:

• Drafts and executes qualification/validation protocols (e.g. IQ/OQ/PQ), including final reports, with support from senior validation personnel as needed.
• Writes and/or revises department and company SOPs (Standard Operating Procedures).
• Authors impact assessments.
• Reviews validation and qualification protocols, including SLIAs/CLIAs (System Level Impact Assessments/Component Level Impact Assessments) written by other validation staff members.
• Serves as Validation representative for cross-functional projects.
• Performs periodic reviews of qualified systems.
• Provides technical assistance to all other departments regarding validation issues.
• Documents and investigates deviations and discrepancies encountered during protocol execution and supports their resolution.
• Maintains the compliance of qualified/validated systems through ongoing validation lifecycle activities (e.g. change control, periodic system reviews).

Job Requirements and Qualifications:

This position is open to candidates with a range of relevant experience levels. Candidates meeting the minimum qualifications are encouraged to apply. Final job level and compensation will be determined based on the selected candidate’s education, experience, skills, and overall qualifications.

Education:

• High School Diploma or G.E.D. required, plus 5 years of relevant experience
• Associate or Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline preferred, plus 2 years of relevant experience

Experience:

• 2+ years of experience conducting validations in a pharmaceutical environment
• Working knowledge of cGMP requirements in a pharmaceutical manufacturing setting
• Experience writing and executing validation protocols and reports
• Previous experience authoring impact assessments and risk assessments
• Demonstrated understanding of functional, design, and user requirement specifications
• Familiarity with developing validation plans
• Effective contributor to cross-functional teams resolving validation issues and completing project tasks
• Strong command of good documentation practices (GDP) and data integrity principles (ALCOA+)
• Knowledge of critical process parameters and how to test them
• Skilled in setting acceptance criteria for qualification/validation processes
• Exposure to software validation practices

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 Savings and Flexible Spending Account options; Employee Assistance Program; generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!