Senior Validation Specialist

Katalyst CRO; Montpelier (VT); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Senior Validation Specialist to lead qualification and validation activities in a GMP environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems in alignment with FDA/EMA requirements.

You will mentor junior staff, collaborate with Engineering, QA, Manufacturing, and Regulatory teams, and drive risk assessments, CAPAs, and change controls to sustain data integrity and

Qualifications

• Bachelor degree in engineering or life sciences or related field.
• 5+ years of validation experience in a GMP environment.
• Strong knowledge of IQ/OQ/PQ, process and equipment validation, CSV and risk assessment.
• Experience with FDA/EMA guidelines and data integrity.
• Excellent technical writing and documentation skills.

Responsibilities

• Lead validation lifecycle activities (DQ/IQ/OQ/PQ) for equipment, facilities, utilities, processes, and systems.
• Author, review, and approve validation protocols, reports, risk assessments, and plans.
• Execute validation activities for equipment, processes, cleaning, utilities, facilities, and computer systems.
• Support C&Q activities for new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls related to validation.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA/EMA and data integrity requirements.
• Support regulatory inspections and audits, collaborate with multi-function teams.
• Mentor junior validation engineers and specialists.

Skills

IQ/OQ/PQ

Process Validation

Equipment Qualification

Cleaning Validation

CSV

Risk Assessments

Change Control & CAPA

Education

Bachelor's degree in Engineering/Life Sciences/Pharma/Chemistry

Tools

MES

LIMS

SCADA

PLC

ERP

Kneat

ValGenesis

TrackWise

MasterControl

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.