Detailed Description :
Incumbents apply in-depth knowledge in a FDA area of specialization. Work is performed within established professional standards and practices.
Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors and a considerable degree of judgement.
Erroneous decisions or failure to achieve results may have a negative impact on the division’s / department’s operations, schedules, and / or performance goals.
Works under minimum Supervision. Seeks approval from others on matters outside of job / role scope. Receives instruction on specific assignment objectives and possible solutions.
Unusual problems are solved jointly with manager. Builds internal and external relationships, with emphasis on those that facilitate the achievement of job / role accountabilities, such as relationships with key suppliers, customers and internal service.
Performs tasks such as, but not limited to, the following :
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 validat ed systems
Knowledge / Skills / Competencies :
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
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.
Good command of written & spoken Spanish preferred
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
Physical Demands :
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.
Occasional overnight travel is required.
Typical Experience :
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.
Typical Education :
Bachelor degree in computer software, industrial, mechanical engineering or electrical engineering.
Training in validation methodologies, technologies and process control computer systems.
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.
COMPANY OVERVIEW :
Celestica (NYSE, TSX : CLS) is a US$5.6 billion global leader in the delivery of end-to-end product lifecycle solutions.
Our customers trust us to deliver the most advanced design, engineering and manufacturing expertise for their highly sophisticated and complex products.
From advanced medical devices, to highly engineered aviation systems, to next-generation hardware solutions for the Cloud, at Celestica we manage the complexity for our customers and set the bar for quality and reliability in their markets.
Our customer portfolio includes leaders in the enterprise computing, communications, aerospace and defense, industrial, smart energy, healthtech and semiconductor markets.
Headquartered in Toronto, our global network spans 13 countries with 26,000 employees throughout the Americas, Europe and Asia.