Senior Validation Engineer - GMP Compliance Leader

Katalyst-Healthcares-; Montpelier (VT); Presencial; USD 100 000 - 140 000; Tempo integral

Resumo da oferta

Creative Solutions Services, LLC in Montpelier, VT seeks an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP environment. You will plan, execute, review, and approve validation docs for equipment, facilities, processes, and computerized systems; ensuring FDA/EMA compliance.

You will mentor junior engineers, manage deviations and CAPAs, and collaborate with cross-functional teams to drive QMS improvements and inspections readiness.

Qualificações

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field.
• Minimum 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of IQ/OQ/PQ, Process Validation, Equipment Qualification, CSV, and CAPA.
• Experience with FDA/EMA guidelines and data integrity requirements; excellent documentation.

Responsabilidades

• Lead validation lifecycle activities including DQ, IQ, OQ, and PQ.
• Author, review, and approve validation protocols, reports, risk assessments, and plans.
• Execute equipment, process, cleaning, utility, facility, and CSV validation tasks.
• Support C&Q of new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA/EMA and data integrity.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory teams.

Conhecimentos

Validation lifecycle

GxP knowledge

Technical writing

Mentorship

Formação académica

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Ferramentas

Kneat

ValGenesis

TrackWise

MasterControl

Descrição da oferta de emprego

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.