Senior Validation Specialist

Katalyst CRO; Frederick (MD); On-site; USD 110,000 - 150,000; 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, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.

Responsibilities include leading DQ/IQ/OQ/PQ lifecycle, authoring validation documents, managing deviations and CAPAs, and collaborating with Quality

Qualifications

• Bachelor-level education in a relevant field is required.
• 5+ years of validation experience in GMP environments.
• Strong knowledge of IQ/OQ/PQ, Process Validation, equipment qualification, CSV.

Responsibilities

• Lead DQ, IQ, OQ, and PQ activities across equipment, facilities, and systems.
• Author, review, and approve validation protocols and reports.
• Manage deviations, investigations, CAPAs, and change controls related to validation.
• Support regulatory inspections and internal audits.

Skills

Validation lifecycle

Regulatory compliance

Documentation & writing

Cross-functional collaboration

Education

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

Tools

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.