Senior Validation Specialist

Katalyst CRO; Baltimore (MD); Sur place; USD 110 000 - 160 000; Plein temps

Résumé du poste

Katalyst CRO is seeking a Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems, ensuring FDA, EMA, and cGMP compliance.

You will collaborate with Engineering, QA, Manufacturing, and Regulatory teams, mentor junior staff, and support regulatory inspections and audits to uphold data integrity and

Qualifications

• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of IQ/OQ/PQ, process validation, equipment qualification, cleaning validation, CSV, risk assessments, change control and CAPA.

Responsabilités

• Lead validation lifecycle activities (DQ/IQ/OQ/PQ).
• Author, review, and approve validation documents and plans.
• Execute validation activities for equipment, processes, utilities, and computerized systems.

Connaissances

Validation lifecycle

IQ/OQ/PQ

Risk assessments

Change control

FDA/EMA knowledge

Formation

Bachelor's degree in a relevant field

Outils

Kneat

ValGenesis

TrackWise

MasterControl

MES

LIMS

SCADA

PLC

ERP

Description du poste

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.