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Skills
Acceptance Testingunmatched
Asepsisunmatched
Biotech and Pharmaceuticalunmatched
Calibrationunmatched
Cleanroomunmatched
Commissioningunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Data Analysisunmatched
Documentationunmatched
Drug Manufacturingunmatched
External Auditunmatched
GMP (Good Manufacturing Practices)unmatched
HVACunmatched
Identify Issuesunmatched
Industry Standardsunmatched
Internal Auditunmatched
Laboratory Information Management System (LIMS)unmatched
Maintain Complianceunmatched
Manufacturing Equipmentunmatched
Manufacturing Systemsunmatched
Manufacturing/Industrial Processesunmatched
Microsoft Officeunmatched
Process Validationunmatched
Project/Program Managementunmatched
Reporting Skillsunmatched
Risk Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Sterilizationunmatched
Technical Supportunmatched
Technical Writingunmatched
Validation Documentationunmatched
Validation Planunmatched
Water For Injection (WFI)unmatched
Writing Skillsunmatched
Description
Position: Validation Engineer / Validation Specialist Location: Maryland Duration: Long Term
Job Overview
We are seeking an experienced Validation Engineer / Validation Specialist to support equipment, utility, and process qualification activities within a GMP pharmaceutical/biotechnology manufacturing environment. The ideal candidate will prepare and execute IQ, OQ, PQ, and Requalification (RQ) protocols, generate validation reports, develop technical documentation, and ensure compliance with cGMP and Good Documentation Practices (GDP).
Key Responsibilities
Prepare, execute, and document IQ, OQ, PQ, and Requalification (RQ) protocols for equipment and utilities.
Generate qualification reports, SOPs, specifications, methods, and other validation documentation.
Develop acceptance criteria based on industry standards, manufacturer recommendations, user requirements, and cGMP guidelines.
Perform thermal mapping studies using Kaye AVS or Veriteq data loggers.
Analyze validation data and verify compliance with acceptance criteria.
Investigate, document, and resolve deviations associated with qualification studies.
Support commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
Prepare technical reports, gap assessments, and risk assessments.
Provide technical support for troubleshooting manufacturing equipment and systems.
Perform technical reviews of qualification documents.
Support internal and external audit readiness activities.
Required Qualifications
Bachelor's degree in Engineering or a related scientific discipline with a minimum of 4 years of validation experience, or 8+ years of relevant validation experience in lieu of a degree.
Experience working in GMP pharmaceutical or biotechnology manufacturing environments.
Hands-on experience with Equipment Qualification (IQ/OQ/PQ/RQ) activities.
Knowledge of cGMP regulations and Good Documentation Practices (GDP).
Experience with aseptic manufacturing processes.
Familiarity with Kaye AVS or Veriteq thermal mapping systems.
Working knowledge of cleanrooms, sterilization equipment, HVAC, WFI, RO, CCA, computerized systems, and isolator technology.
Experience with Microsoft Office, EDMS, LIMS, and related documentation systems.
Strong technical writing, communication, organizational, and project management skills.
Ability to work independently and collaboratively in a cross-functional environment.
Knowledge of maintenance and calibration procedures is preferred.