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Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Turkey"],"countries":["TR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":36000,"max_usd":78000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":5668},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-05-12T00:00:00Z","employer_posted_date":"2026-05-12","last_verified_at":"2026-11-15T04:06:57Z","board_verified":true,"closed_at":null,"days_open":187,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":186},"description":"Job Description\nResponsible for CSV remediation and compliance activities related to computerized systems and equipment used in sterile manufacturing operations,\nPlanning and implementing corrective, preventive, and improvement actions to ensure compliance with GMP and CSV requirements,\nPreparing, reviewing, and executing CSV documentation, including URS, FS/DS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and validation reports,\nPerforming retrospective validation and gap assessment/remediation activities for computerized systems,\nSupporting lifecycle management activities, including periodic review, change control, deviation management, CAPA follow-up, backup verification, and audit trail review,\nApplying risk-based decision-making principles in validation and compliance activities,\nProviding technical and compliance support during customer and regulatory authority inspections,\nCoordinating with third-party vendors and service providers involved in GMP-regulated CSV and automation projects,\nCollaborating with QA, Engineering, Production, and IT teams to ensure sustainable CSV compliance,\nDefining investment, improvement, and revision needs for current and future GMP-CSV compliance and industrial automation requirements,\nEnsuring all validation activities are performed in accordance with applicable GMP regulations, internal procedures, and global data integrity expectations.\nQualifications\nGraduated from Computer Engineering, Software Engineering, or Automation Engineering departments of universities,\nStrong knowledge of computerized systems and industrial automation processes,\nMinimum 3 years of experience in plant CSV activities and 21 CFR Part 11 compliance projects within manufacturing environments,\nStrong knowledge of GAMP5, EU GMP Annex 11 and Annex 15 guidelines, PLC and HMI systems, and backup processes,\nExperienced in troubleshooting, equipment commissioning, system implementation, and retrospective validation activities,\nPreferably experienced in the pharmaceutical industry (sterile manufacturing),\nProficient in 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