Senior Validation Lead – GMP Compliance & QA Impact

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

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