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- 投稿済み
- 3時間前
- 作業モード
- 在宅勤務
- 再開する
- 応募必須
仕事内容
Position Overview
We are looking for a motivated Entry-Level CSV Engineer to support the validation of computerized systems crucial in pharmaceutical and life sciences sectors. The candidate will play an integral role in ensuring systems meet regulatory and compliance standards, focusing on reliability and adherence to quality frameworks.
Key Responsibilities
- Assist with validation activities of computerized systems including LIMS, ERP, SCADA, and MES.
- Develop and carry out validation documentation such as User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Support adherence to Good Manufacturing Practice (GMP) and 21 CFR Part 11 regulations.
- Contribute to risk assessment procedures and validation planning processes.
- Maintain documentation in line with Good Documentation Practices (GDP).
- Support audit and inspection activities as required.
- Collaborate closely with Quality Assurance, Information Technology, and Engineering departments.
- Assist in managing change controls, deviations, and Corrective and Preventive Actions (CAPA).
- Ensure data integrity and maintain system compliance consistently.
Skill Set Requirements
- Basic understanding of Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP) with knowledge of validation lifecycle phases including URS, IQ, OQ, and PQ.
- Experience or familiarity with computerized system operations and principles of data integrity.
- Strong skills in documentation, analysis, and problem-solving.
- Effective communication capabilities coupled with basic IT competency.
Preferred Qualifications
- Experience or knowledge of systems such as LIMS, SAP, MES, and SCADA.
- Understanding of ISO 9001 standards and GxP-regulated environments.
- Awareness of data integrity concepts, specifically ALCOA+ principles.
- Previous internship or academic projects related to validation, quality assurance, or IT systems in regulated industries.