- 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/, EU GMP/MDR, ISO /).
- Supports validation projects that use Software Development Life Cycle (SDLC) methodologies (ex: waterfall, agile). Creates, executes, and reviews validation deliverables within an SDLC process.
- Independently manages the CSV workstream deliverables of a project or change requests. Seeks support from management, other team members, or Subject Matter Experts (SMEs) as needed. Supports others in understanding and applying validation procedures.
- 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 minimal 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.
- Strong understanding of the main industry validation frameworks, ex: GAMP 5, FDA CSA.
- Knowledge of the regulatory requirements and standards, ex: FDA Parts 11/, EU GMP/MDR, ISO /
- 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 minimal 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.
- Duties of this position are performed in a normal office environment.
- Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data. Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.
- Travel is on need basis only, and is expected to be around 10-15% of the time.
- 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.
- 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.
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08 - Specialist, Computer System Validation - Suzhou Shi, 中国 - Celestica
描述
Req ID:
Remote Position: Hybrid
Region: Asia
Country: China
State/Province: Jiangsu Province
City: Suzhou
General Overview
Functional Area: Information Technology (ITM)
Career Stream: IT Risk & Compliance (RAC)
Role: Specialist (SPE)
Job Title: Specialist, Computer System Validation
Job Code: SPE-ITM-SYSV
Job Level: Band 8
Direct/Indirect Indicator: Indirect
Summary
The Computer System Validation (CSV) Specialist role is a global enterprise role. The Specialist manages the validation deliverables for computer systems to support product quality and compliance with internal/external standards, procedures, and regulations. The role requires applying specialized validation and regulatory knowledge mainly in the Medical Devices manufacturing area. The role's responsibilities require a high level of independence, proactiveness, ownership, accountability, and communication (written/verbal) with diverse and global stakeholders and teams. The role also requires deep analysis, critical thinking, judgment calls, prioritization, continuous learning, and supporting/training others. (#LI-JW)
Detailed Description
Performs tasks such as, but not limited to, the following:
Knowledge/Skills/Competencies
Physical Demands
Typical Experience
Typical Education
Notes
This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.
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).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
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, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
