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Computer System Validation

3 weeks ago

Singapore Celestica Full time

Req ID: 119781
Remote Position: Hybrid
Region: Asia
Country: Singapore
State/Province: Serangoon North

**Summary**:
**Detailed Description**:
Performs tasks such as, but not limited to, the following:

- Develops and executes validation plans, deliverables, and procedures that are consistent with the Celestica standards and the industry validation frameworks and principles (ex: GAMP 5, FDA CSA).
- Applies regulatory requirements and standards to systems, processes, and projects (ex: FDA Parts 11/820, EU GMP/MDR, ISO 9001/13485).
- Supports validation projects that use Software Development Life Cycle (SDLC) methodologies (ex: waterfall, agile). Creates, executes, and reviews validation deliverables within an SDLC process.
- Analyzes a system’s intended use, business/technical processes, data flows, requirements, design, suppliers, and/or operations to identify GxP impacts and risks for projects and change requests. Recommends mitigations and approaches to handle GxP risks and impacts.
- Creates risk-based validation plans and reports for diverse business/technical systems, projects, and change requests. Creates and scales the rigor of validation deliverables based on the risk assessments.
- Analyzes and suggests improvements to operational change controls and configuration management procedures for GxP systems.
- Creates, maintains, and updates documents/records in accordance with regulatory standards and company procedures. Recommends records management approaches and improvements for GxP systems and projects.
- Supports the administration of the CSV documentation and records system with mínimal supervision.
- Reviews validation deliverables created by others for suitability, accuracy, and completeness.
- Supports the CSV deliverables of periodic reviews and internal/external audits collaborating with cross-functional teams. Identifies and reports any deviations or non-conformance findings.
- Develops, reviews and/or revises policies, procedures, and guidelines for the CSV Program. Identifies gaps and improvement areas in the CSV Program and proposes solutions to address them.

**Knowledge/Skills/Competencies**:

- Strong understanding of the main industry validation frameworks, ex: GAMP 5, FDA CSA.
- Knowledge of the regulatory requirements and standards, ex: FDA Parts 11/820, EU GMP/MDR, ISO 9001/13485
- Knowledge and familiarity with the following type of the systems is preferred, but not mandatory: Manufacturing Execution Systems (MES, ex: Siemens, Plex), Quality Management Systems (QMS, ex: EtQ), Enterprise Resource Planning (ERP, ex: SAP), Product Lifecycle Management Systems (PLM, ex: Enovia).
- Ability to continuously learn new technologies and business processes and operations willingly and proactively.
- Ability to work and think critically, independently, and proactively with mínimal supervision.
- Ability to take end-to-end accountability and responsibility to drive assignments and projects to completion.
- Strong communication (written and verbal) skills in English.
- Ability to build relationships and communicate effectively with diverse and global business/technical stakeholders and teams.
- Strong project and team management and collaboration skills.

**Typical Experience**:

- 3 to 5 years of CSV, QA, and/or Business/System Analysis experience.
- Preferred, but not mandatory, experience in the Medical Device manufacturing industry, other HealthTech regulated industries such as Pharmaceuticals, and/or the electronics manufacturing industry

**Typical Education**:

- Bachelor degree in computer science, engineering (computer, industrial, mechanical, electrical), business/information system management, or equivalent.
- Training in validation methodologies, technologies, and process control computer systems.

**Notes**:
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).

**COMPANY OVERVIEW**:
Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development - from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, d