Validation Specialist
Scientific Protein Laboratories
Summary
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.
Job description
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).
Requirements
- 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
- 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
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-term Disability
- Health Savings Account
- Flexible Spending Account
- Employee Assistance Program
- Generous Vacation
- Paid Holidays
- 401(k)
- Advancement Opportunities
Company overview
Scientific Protein Laboratories (SPL) is a leading global supplier of high-quality active pharmaceutical ingredients (APIs) with over four decades of experience in the pharmaceutical manufacturing industry. Founded in 1976 in Waunakee, Wisconsin, the company specializes in cGMP biopharmaceutical manufacturing and is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. SPL serves pharmaceutical, veterinary, and food industries worldwide, operating manufacturing facilities in both Waunakee, Wisconsin and Sioux City, Iowa. The company focuses on extracting, isolating, and purifying naturally-derived materials from animal and plant sources, with particular expertise in porcine-sourced starting materials. As a subsidiary of Shenzhen Hepalink Pharmaceutical since 2014, SPL maintains a strong commitment to regulatory compliance and quality assurance, operating strictly in accordance with FDA's cGMP requirements while providing comprehensive regulatory support to its global customer base.