Overview
Validation Specialist Jobs in United States at Invent Staffing
Title: Validation Specialist
Company: Invent Staffing
Location: United States
Key Responsibilities:
Develop and execute cleaning validation lifecycle documentation including protocols (IQ/OQ/PQ), risk assessments, and master plans.
Conduct swab and rinse sampling for chemical and microbiological residue testing post-cleaning.
Evaluate and validate cleaning procedures for critical manufacturing equipment (e.g., bioreactors, tanks, isolators, filling lines).
Perform worst-case assessments for cleaning validation limits using criteria such as potency, toxicity, solubility, and batch size.
Collaborate with cross-functional teams (Quality Assurance, Manufacturing, Engineering, and Analytical) to establish effective and compliant cleaning strategies.
Support cleaning verification programs and assist in transitioning from cleaning verification to full validation.
Analyze and trend results from cleaning validation studies, investigate deviations, and support CAPA implementation.
Maintain and revise cleaning validation documentation to align with regulatory updates and internal procedures.
Participate in internal and external audits; serve as subject matter expert for cleaning validation.
Train manufacturing and quality personnel on cleaning validation requirements and best practices.
Qualifications:
Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Biotechnology, Chemical Engineering, or a related scientific discipline.
3–7 years of hands-on experience in cleaning validation within the pharmaceutical or biopharmaceutical industry.
Strong knowledge of applicable regulatory guidelines (FDA, EMA, ICH, WHO).
Proficient in analytical methods such as HPLC, TOC, conductivity, and visual inspection.
Experience with risk-based validation approaches, including HBEL, PDE, and MACO calculations.
Familiarity with cleaning agents and CIP/manual cleaning systems.
Excellent technical writing, documentation, and communication skills.
Strong project management and organizational abilities.
Preferred Qualifications:
Experience supporting regulatory inspections.
Knowledge of computerized validation systems and data integrity principles.
