Senior Validation Lead - GMP & CSV Specialist

Katalyst-Healthcares-; Cincinnati (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC 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, ensuring FDA/EMA compliance.

The role requires 5+ years in GMP validation, strong technical writing, and collaboration with QA, Manufacturing, and Regulatory teams.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field.
• 5+ years of validation experience in a GMP-regulated environment.
• Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
• Excellent technical writing and documentation skills.
• Knowledge of IQ/OQ/PQ, Process Validation, Equipment Qualification, Cleaning Validation, CSV, Risk Assessments, Change Control and CAPA.

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 CSV activities.
• Support C&A 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, 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

Computer System Validation

Risk Assessments

Change Control & CAPA

Technical writing

Education

Bachelor's degree in Engineering/Life Sciences/Biotech/Pharmacy/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.