Computer System Validation Specialist

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

- **Plans, analyzes and documents validation deliverables for computerized systems involved in the manufacturing and quality management processes and data. Ex. Manufacturing Execution Systems (MES), Quality Management Systems (QMS), Enterprise Resource Planning (ERP, ex SAP)**:

- **Applies CSV best practices and frameworks, such as GAMP 5, ISO, FDA**:

- Gathers business requirements and prepares FDA/ISO compliant documents based on those requirements
- Conduct risk analysis to identify system/software and process controls
- Interacts with Health Tech business community to understand the business process and contribute to the evaluation of software tools/systems that can be leveraged to optimize the business process
- Ensures team members are provided with timely and accurate project information and status
- Ensures all systems are running in compliance with company and site policies
- Manages validation adjustments or improvements to software systems

**Knowledge/Skills/Competencies**:

- Bachelor degree in computer software, industrial, mechanical engineering or electrical engineering.
- Training in validation methodologies, technologies and process control computer systems.
- **3 to 5 years of IT CSV experience preferably in medical device manufacturing, or in other HealthTech regulated industries such as pharmaceuticals**:

- **Knowledge of regulations related to medical device manufacturing: CFR Part 820, 210, 211, 21 CFR Part 11, ISO 13485, ISO 14971**:

- **Proven skills in leading CSV projects, with 3 years experience in developing and managing validation plans and deliverables (ex: protocols, scripts, reports) for projects and change requests following CSV best practices and frameworks, such as GAMP 5, ISO, FDA**:

- Ability to analyze and understand business requirements and technical specifications
- Ability to identify, gather, analyse and properly document system and process architecture and requirements
- Ability to conduct GxP assessments on projects and change requests
- Capable of performing risk analysis using tools such as FMEA
- Capable of ensuring that documents and quality practices meet quality standards and applicable regulatory conformance
- Very good command of written & spoken English.
- Proven skills in project management
- Organization and time management with little overall supervision.
- Excellent technical knowledge in specialized domains (ex, manufacturing, QMS, ERP, cloud)
- Knowledge of development frameworks in an Windows Client/Server Platform or Unix Client/Server Platform
- Strong written and verbal communication skills with the ability to work through technical issues with stakeholder both remotely and in person
- This position requires a high energy level and a passion for excellence.

Work Location**:Blk 35, Marsiling Industrial Estate Road 3 Woodlands Ave 5 Singapore 739257**
- 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, 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.