Senior Validation Specialist

Katalyst CRO; Richmond (VA); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Katalyst CRO seeks a Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment in the United States. You will plan, execute, review, and approve validation documentation for equipment, facilities, and computer systems while ensuring FDA/EMA/cGMP compliance.

You will mentor junior staff, support audits, and collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory groups to maintain data integrity and quality systems.

Formación

• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of IQ/OQ/PQ, Process Validation, Equipment Qualification, Cleaning Validation, CSV.
• Experience with FDA/EMA guidelines and data integrity basics.

Responsabilidades

• Lead validation lifecycle activities (DQ/IQ/OQ/PQ) for equipment, facilities, utilities, processes, and computerized systems.
• Author, review, and approve validation protocols, reports, risk assessments, and plans.
• Manage deviations, CAPAs, change controls, and support regulatory inspections.
• Mentor junior validation engineers and collaborate with QA, Manufacturing, and Regulatory teams.

Conocimientos

Validation lifecycle

GMP compliance

Technical writing

Regulatory audits

Educación

Bachelor's degree in Engineering or Life Sciences

Herramientas

Kneat

ValGenesis

TrackWise

MasterControl

Descripción del empleo

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.