A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
Validation Specialist Katalyst Healthcares & Life Sciences - 4.0 Charleston, SC Job Details Contract 3 hours ago Qualifications Quality control corrective actions GAMP Content creation for technical audiences Technical documentation Pharmaceutical regulatory compliance Preventive action implementation Technical writing experience within manufacturing Production deviation management Corrective and preventive actions (CAPA)
FDA 21 CFR
Part 11 Internal investigations Production validation processes Quality assurance experience within pharmaceutical industry Biomedical regulatory compliance Risk assessment implementation Cleaning and sanitation quality assurance
Full Job Description Job Description:
We are seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. The ideal candidate will be responsible for planning, executing, reviewing, and approving validation documentation for equipment, facilities, utilities, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.
Responsibilities:
Lead validation lifecycle activities including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Author, review, and approve validation protocols, reports, risk assessments, and validation plans. Execute equipment, process, cleaning, utility, facility, and computer system validation activities. Support commissioning and qualification (C&Q) activities for new equipment and manufacturing systems. Manage deviations, investigations, CAPAs, and change controls related to validation activities. Develop and maintain Validation Master Plans (VMPs). Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements. Support regulatory inspections and internal/external audits. Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams. Mentor junior validation engineers and specialists.
Requirements:
Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related field. 5+ years of validation experience in a GMP-regulated environment.
Strong knowledge of:
IQ/OQ/PQ
Process Validation Equipment Qualification Cleaning Validation Computer System Validation (CSV) Risk Assessments Change Control and CAPA Experience with
FDA, EMA, 21 CFR
Part 11, and GAMP 5 guidelines. Excellent technical writing and documentation skills.
Preferred Qualifications:
Experience with MES, LIMS, SCADA, PLC, ERP, or other GMP computerized systems. Knowledge of Kneat, ValGenesis, TrackWise, MasterControl, or similar validation tools. Experience supporting audits and regulatory inspections. Validation certification or advanced degree preferred.
