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Overview You are specialized in the design, implementation, and qualification of manufacturing systems, utility infrastructures, and automation technologies. Your work ensures that engineering solutions consistently meet high standards for quality, safety, and productivity, while fully complying with global regulatory frameworks such as cGMP and FDA guidelines. Key ResponsibilitiesBody of Knowledge & StandardsDevelop and maintain CQV standards, SOPs, and technical guidelines.Provide expert feedback on project compliance and mentor engineers on best practices.Support readiness for regulatory inspections and internal audits.Engineering ProjectsLead CQV scope across project phases: design, commissioning, qualification.Define and execute CQV plans, manage resources, and mitigate risks.Coordinate cross-functional teams and ensure seamless project delivery.Technical ServicesResolve complex equipment/system challenges with a focus on compliance and performance.Author and review technical documentation (IQ/OQ protocols, test reports, SOPs).Conduct root cause analysis and implement CAPAs for system deviations.Deliver training and support documentation for operations and maintenance teams.Scope & ImpactManage vendor scopes and contribute to project budget estimations.Ensure lifecycle compliance and mentor junior staff in change management and deviation resolution. We are looking to recruit a Candidate: Qualifications & ExpertiseEducation: University degree in Engineering (Chemical, Mechanical, Electrical, Automation) or related scientific field.Experience: 5+ years in CQV, with strong exposure to system design, implementation, and qualification in pharma/chemical industries.Technical Skills:Deep understanding of GMP, GAMP, and engineering compliance.Proficient in MS Office, CAD tools, and digital design platforms.Fluent in English (written and spoken).Core CompetenciesAdvanced problem-solving and analytical thinking.Independent contributor with leadership in project teams.Strong communication and mentoring capabilities.
