What are the responsibilities and job description for the Validation Engineer position at Harba Solutions Inc.?
Job Responsibilities:
- Develop, execute, and review commissioning, qualification, and validation protocols for manufacturing systems and equipment
- Support validation lifecycle activities including URS, risk assessments, FAT, SAT, IQ/OQ/PQ, and summary reporting
- Execute qualification activities for facilities, utilities, process equipment, and packaging systems within GMP-regulated environments
- Document test execution results, deviations, investigations, and corrective actions in accordance with compliance standards
- Coordinate project activities with engineering teams, operations, vendors, contractors, and quality groups
- Ensure validation documentation is audit-ready and aligned with FDA, cGMP, ASTM E2500, ISPE, and industry guidelines
- Support change controls, SOP revisions, periodic reviews, and requalification activities
- Collect, review, and analyze validation data to support project deliverables and compliance initiatives
- Assist with project scheduling, resource coordination, and progress tracking to support project timelines
- Mentor junior team members and contribute to continuous improvement and knowledge-sharing initiatives
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field
- 2-5 years of experience in commissioning, qualification, validation, or related engineering activities within pharmaceutical, biotech, chemical, or regulated manufacturing environments
- Experience supporting GMP-regulated manufacturing and validation lifecycle activities
- Familiarity with FDA regulations, cGMP requirements, ASTM E2500, ISPE guidelines, and risk-based validation approaches
- Experience authoring and executing validation documentation including IQ/OQ/PQ protocols and risk assessments
- Strong technical writing, organizational, and problem-solving skills
- Ability to manage multiple priorities and communicate effectively with cross-functional teams and clients
- Experience with validation tools, temperature mapping systems, or electronic validation platforms such as Kneat, Kaye Validator, ValProbe, Ellab, or similar systems is preferred