We are seeking a detail-oriented and highly analytical Validation Engineer to join our remote team. In this role, you will be responsible for ensuring that systems, processes, and products meet defined requirements, regulatory standards, and quality expectations. You will play a critical role in validating software, systems, and equipment to support operational excellence and compliance across projects.
Key Responsibilities
Validation & Testing Execution
Develop, review, and execute validation protocols (IQ, OQ, PQ) for systems, software, and equipment.
Perform system validation, data integrity checks, and process verification activities.
Document validation results, deviations, and corrective actions in accordance with company and regulatory standards.
Quality & Compliance
Ensure all validation activities comply with industry standards (FDA, GMP, GxP, ISO where applicable).
Maintain accurate validation documentation and audit-ready records.
Support internal and external audits, providing validation evidence and reports as required.
Cross-Functional Collaboration
Work closely with engineering, QA, IT, and operations teams to define validation requirements.
Translate technical and regulatory requirements into clear validation strategies and deliverables.
Provide guidance on validation best practices and risk mitigation.
Process Improvement
Identify opportunities to streamline validation processes and improve efficiency.
Contribute to continuous improvement initiatives and standardization of validation procedures.
Support implementation of new systems and technologies with validation expertise.
Required Qualifications
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field
3+ years of experience in validation engineering, quality assurance, or system validation
Strong knowledge of validation lifecycle (IQ/OQ/PQ) and documentation practices
Experience with regulatory frameworks such as FDA, GMP, GxP, or ISO standards
Familiarity with software validation, CSV (Computer System Validation), or equipment validation
Excellent analytical, problem-solving, and documentation skills
Strong communication skills with the ability to work effectively in a remote environment
Preferred Qualifications
Experience in pharmaceutical, biotech, medical device, or regulated industries
Knowledge of validation tools, automation testing, or scripting (e.g., Python, SQL)
Certification in Quality or Validation (e.g., ASQ, Six Sigma)
Experience with ERP, LIMS, MES, or cloud-based systems
Compensation & Benefits
Flexible remote work environment
Opportunity to work on high-impact, compliance-driven projects
Access to professional development and certification support
Collaborative and growth-focused team culture.