Validation Engineer

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.