Senior Validation Specialist

Katalyst CRO; Frederick (MD); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking an experienced 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 in compliance with FDA, EMA, and cGMP.

Collaborating with Engineering, QA, Manufacturing and Regulatory teams, you will mentor junior staff and support audits and regulatory inspections.

Qualifications

• 5+ years of validation experience in a GMP-regulated environment.
• Experience leading qualification activities (DQ/IQ/OQ/PQ).
• Strong knowledge of validation lifecycle, risk assessments, CAPA and change controls.
• Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
• Excellent technical writing and documentation skills.

Responsibilities

• Lead validation lifecycle activities including DQ, IQ, OQ and PQ.
• Author, review, and approve validation protocols, reports, risk assessments, and validation plans.
• Execute validation activities for equipment, processes, utilities, and computerized systems.
• Support commissioning and qualification (C&Q) activities for new equipment and systems.
• Mentor junior validation engineers and specialists; collaborate with QA, Manufacturing, Engineering and Regulatory teams.

Skills

DQ/IQ/OQ/PQ

CSV

FDA/EMA knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MES

LIMS

SCADA

PLC

ERP

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.

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.