Senior Validation Engineer - GMP Compliance Lead

Katalyst CRO; Charleston (SC); On-site; USD 90,000 - 130,000; 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, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.

Responsibilities include leading DQ/IQ/OQ/PQ, authoring validation plans and reports, and mentoring junior staff.

Qualifications

• Bachelor's degree in a related field required or equivalent experience.
• 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.
• 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/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 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 audits.
• Collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory teams.
• Mentor junior validation engineers and specialists.

Skills

IQ/OQ/PQ

Process Validation

Equipment Qualification

Cleaning Validation

CSV (Computer System Validation)

Risk Assessments

Change Control & CAPA

Education

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field

Tools

Kneat

ValGenesis

TrackWise

MasterControl

MES

LIMS

SCADA

PLC

ERP

Job description

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, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.

Responsibilities include leading DQ/IQ/OQ/PQ, authoring validation plans and reports, and mentoring junior staff.