Suru · 13 hours ago
Validation Engineer
Miami, FL
Full-time
Onsite
Mid, Senior Level
$80K/yr - $120K/yr
2+ years expSuru is seeking a Validation Engineer responsible for ensuring the reliability, consistency, and regulatory compliance of manufacturing processes and systems. The role involves leading validation documentation and activities while managing projects and providing technical guidance.
Staffing & Recruiting
Hiring Manager
Steven Scott
Responsibilities
Lead the preparation, execution, and review of validation documentation, including:
User Requirements Specifications (URS)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Validation Summary Reports (VSR)
Independently lead and coordinate cross-functional validation projects, ensuring timelines, scope, and deliverables are met
Perform critical review of Validation Engineer project plans and validation documentation to ensure accuracy, completeness, and compliance
Develop and execute validation plans for new and existing processes, equipment, and computerized systems
Execute process validation and equipment qualification activities, including defining acceptance criteria, troubleshooting equipment, and ensuring compliance with safety and quality standards
Support and maintain the company Master Validation Plan (MVP), including commissioning activities, protocol execution, and revalidation criteria
Assess the validation impact of process, material, equipment, or system changes and provide guidance on change control and revalidation requirements
Conduct impact and risk assessments in collaboration with system owners to determine qualification and validation needs
Identify validation and manufacturing risks and implement effective mitigation strategies
Review technical data and validation results, and present findings to internal stakeholders and management
Support validation activities related to sterilization processes and micro validation efforts
Ensure compliance with all applicable federal, state, regulatory, and company policies and procedures
Coordinate external validation or testing services when required
Perform additional duties as assigned
Qualification
Required
Bachelor's degree in Engineering or a related technical discipline (e.g., Biology, Chemistry); microbiology background preferred
2–5 years of experience in an engineering role, with hands-on validation experience preferred
Experience in regulated industries such as Tissue Banking, Pharmaceutical, Medical Device, or Biologics
Strong knowledge of regulatory and quality guidelines (e.g., FDA, AATB, cGTP preferred)
Experience with process validation and equipment validation
Nonconformance, deviation, complaint handling, and CAPA processes
Sterilization validation (strong plus)
Microvalidation / microbiological validation (strong plus)
Proficiency with Microsoft Word, Excel, PowerPoint, and Project
Strong analytical, problem-solving, and technical writing skills
Effective verbal and written communication and presentation abilities
Project management capability with the ability to manage multiple priorities
Ability to work independently, influence others, and lead change across cross-functional teams
Company
Suru
Suru is a specialized recruiting firm focused on delivering top-tier talent for direct hire and temporary placements across a wide range of industries.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase