Celestica Electronics (M) Sdn Bhd Vacancies Computer System Validation Specialist
Celestica Electronics (M) Sdn Bhd is looking for new potential candidates to fill in for Computer System Validation Specialist position. If you currently looking for new job opportunities and qualified with the job desc, feel free to apply this job.
Job Description
Job Responsibilities:
● Gathers Business Requirements and prepares FDA compliant documents based on those requirements.
● Interacts with the business community and customers to understand business processes and define tools can be leveraged to optimize the business process.
● Ensures team members are provided with timely and accurate project information and status updates.
● Ensure all systems are running in compliance with company and site policies.
● Plan, Analyse and document tests for Manufacturing Execution Systems and other site systems in compliance with FDA regulations.
● Lead application validation.
● Manage adjustments or improvements to equipment and processes.
● Lead risk analysis to identify system and process controls.
● Assessment of changes and impact on validated systems
● Interacts with the business community and customers to understand business processes and define tools can be leveraged to optimize the business process.
● Ensures team members are provided with timely and accurate project information and status updates.
● Ensure all systems are running in compliance with company and site policies.
● Plan, Analyse and document tests for Manufacturing Execution Systems and other site systems in compliance with FDA regulations.
● Lead application validation.
● Manage adjustments or improvements to equipment and processes.
● Lead risk analysis to identify system and process controls.
● Assessment of changes and impact on validated systems
● Ability to Identify, gather, analyse and properly document system requirements.
● Capable of ensuring that documents plus practices attain quality standards and applicable regulatory conformance.
● Capable of performing risk analysis using tools such as FMEA
● Capable of implementing software validation engineering test plans, test cases/scripts.
● Ability to propose solutions and collaborate in software validation procedures and processes.
● Proven skills on implementation of computerized system validation projects with 3 years in developing computerized system validation plan and protocols.
● Strong written and verbal communication skills with the ability to work through technical issues with customers both remotely and in person.
● In-depth knowledge of object oriented languages (Java, C++) and or good knowledge of scripting languages (Visual Basic, VB Script, JavaScript, HTML, Perl) and relational Data Bases and SQL.
● Ability to analyze and understand business requirements and to design solution specifications.
● This position requires a high energy level and a passion for excellence.
● Very good command of written & spoken English.
● Proven skills in projects management.
● Organization and time management with little overall supervision.
● Excellent technical knowledge in specialized domains.
● Knowledge of development in an Windows Client/Server Platform or Unix Client/Server Platform
● Capable of ensuring that documents plus practices attain quality standards and applicable regulatory conformance.
● Capable of performing risk analysis using tools such as FMEA
● Capable of implementing software validation engineering test plans, test cases/scripts.
● Ability to propose solutions and collaborate in software validation procedures and processes.
● Proven skills on implementation of computerized system validation projects with 3 years in developing computerized system validation plan and protocols.
● Strong written and verbal communication skills with the ability to work through technical issues with customers both remotely and in person.
● In-depth knowledge of object oriented languages (Java, C++) and or good knowledge of scripting languages (Visual Basic, VB Script, JavaScript, HTML, Perl) and relational Data Bases and SQL.
● Ability to analyze and understand business requirements and to design solution specifications.
● This position requires a high energy level and a passion for excellence.
● Very good command of written & spoken English.
● Proven skills in projects management.
● Organization and time management with little overall supervision.
● Excellent technical knowledge in specialized domains.
● Knowledge of development in an Windows Client/Server Platform or Unix Client/Server Platform
Job Requirements :
● Bachelor degree in computer software, industrial, mechanical engineering or electrical engineering.
● Training in validation methodologies, technologies and process control computer systems.
● Training in validation methodologies, technologies and process control computer systems.
● 3 - 5 years of IT computer validation with experience in medical device manufacturing operation.
● Experience in a regulated environment with in depth knowledge and experience with cGMPs/GLPs/GAMP regulations related to medical device manufacturing systems, CFR Part 820, 210, 211, 21 CFR Part 11, ISO 13485, ISO 14971.
● Experience in a regulated environment with in depth knowledge and experience with cGMPs/GLPs/GAMP regulations related to medical device manufacturing systems, CFR Part 820, 210, 211, 21 CFR Part 11, ISO 13485, ISO 14971.
● 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.
● Occasional overnight travel is required.
● Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.
● Occasional overnight travel is required.
● Applicants must be willing to work in Senai,Johor.
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.
How To Apply
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