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Senior Validation Specialist

Karwell Technologies

Frederick, MD

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Code of Federal Regulations, Commissioning, Computer Systems, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Quality, ERP (Enterprise Resource Planning), Equipment Validation, External Audit, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), GxP, Internal Audit, Laboratory Information Management System (LIMS), Maintain Compliance, Manufacturing Automation, Manufacturing Systems, Mentoring, Pharmacy, Process Validation, Programmable Logic Controller (PLC), Quality Assurance, Regulations, Risk Analysis, Sales Qualification, Supervisory Control and Data Acquisition (SCADA), System Validation, Technical Writing, Validation Documentation, Validation Plan, Writing Skills
LOCATION
Frederick, MD
POSTED
3 days ago
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.

About the Company

K

Karwell Technologies

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