Process Validation Engineer

Job Title: Process Validation EngineerDurations: Long-TermJob Description & Skill Requirements:• Lead and execute Process Validation and Equipment Qualification (IQ/OQ/PQ) activities.• Prepare and review validation documents including Validation Plans, Protocols, Reports, Risk Assessments, and Engineering Studies.• Support Change Management for Products (CMP) activities involving manufacturing processes, product design, and supplier changes.• Coordinate documentation updates, reviews, approvals, and implementation activities.• Work closely with Engineering, Manufacturing, Quality, Supplier Quality, and Operations teams.Required Skills:• Strong experience in Process Validation and Equipment Qualification (IQ/OQ/PQ).• Knowledge PLM Agile , Change Orders & DMCO• Knowledge of Medical Device manufacturing processes.• Experience with Change Control and Change Management processes.• Understanding of FDA, ISO 13485, and Quality Management Systems.• Experience in Risk Assessment (FMEA), Engineering Studies, and Validation Documentation.• Strong documentation and project coordination skills.• Ability to work effectively with cross-functional teamsPriority 1:• Process Validation & IQ/OQ/PQ• PLM Agile, Change Orders & DMCO – Hands-on• Medical Device Manufacturing• Change Control / Change Management• FDA / ISO 13485 / QMS• FMEA / Risk AssessmentPriority 2:• Validation Documentation• Manufacturing Transfer• CAPA / Deviation Investigations• Engineering Studies• Process ImprovementEducation & ExperienceBachelor's in Engineering / Manufacturing / Mechanical / Chemical / BiomedicalPrioritize strong hands-on validation experience.Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.Equal Employment Opportunity:Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.