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Computer System Validation Manager - Medical Device Manufacturing

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Date: Feb 1, 2019

Location: Toronto, CA

Company: Celestica International Inc.

Req ID: 40685 
Region: Americas 
Country: Canada 
State/Province: Ontario 
City:  Toronto 

 

What’s in it for you?

When you join Celestica, it’s more than just a job. It’s about being part of a team of talented individuals who are passionate about what they do every day, and contributing to our forward thinking and collaborative solutions for our teams and customers. 

 

Detailed Description

The Computer System Validation Manager provides direct supervision to others, or indirect through subordinate supervisors, and coordinates the activities of a section with responsibility for results in terms of costs, methods, and employees. Reviews employees’ performance and recommends employee compensation; coaches for improved performance and disciplines as necessary.  Establishing long term plans/objectives, and developing validation processes and policies for the function/unit. Accountable for projects or programs on a multi-functional, national, or regional basis. Builds cross-functional relationships where persuasive skills, negotiation skills, and considerable tact are required to gain support. Interacts regularly with senior management or executive levels on matters concerning several functional areas, divisions and/or customers. Maintains positive relationships with internal stakeholders, key customers, FDA, etc., who have a significant impact on the success of the organization.

 

Performs tasks such as, but not limited to, the following:

  • Build the Computer System Validation and compliance program for Celestica's Health Tech market segment. 
  • Partner with Global Quality to ensure requirements are met for Good Manufactured Product according to FDA 21CFR Part 11 and other applicable regulations. 
  • Work with Enterprise Architecture and IT Platform leads in both Functional IT and GBS E2R teams to execute validation and change control processes impacting Health Tech products. 
  • Drive continuous improvement to validation software, processes and capabilties to improve overall quality, compliance and efficiency.

 
Knowledge/Skills/Competencies:

  • Experience shall include validation of Computer Systems, investigations, and change control in a medical device manufacturing environment. 
  • Good understanding of GMP’s and GAMP standards including validation process. 
  • Knowledge of FDA 21CFR Part 11 and other applicable regulations. 
  • Experience at writing/executing validation plans, IQ, OQ and PQ qualification protocols and reports for computer systems. 
  • Relevant experience on Client/Server applications; RDMS Database (SQL Server) applications; SAP system, e-Validator, Equipment Control validation (PLC/SCADA), Network and Enterprise Content Management Systems. 
  • Experience in hosting/defending internal or external audits. 
  • Ability to effectively communicate with Business SME’s, IT team members as well as business users across the globe (Excellent verbal and written communication skills) 
  • Strong emphasis on customer service and interpersonal skills. 
  • Self-starter with good organizational and prioritization skills. 
  • Effective team player and ability to work in a rapidly changing environment. 
  • Position requires proficient personal computer skills including electronic mail, spreadsheets and graphics. Advanced skills in Excel and Word preferred. 
  • Knowledge of Software Testing Tools is preferred. 
  • Manufacturing Industry experience highly desired. 
  • Occasional overnight travel is required, with the ability to travel around 25-50%. 

 

Experience:

  • 10 years computer validation experience in health science industry. 
     

Education:

  • Bachelor’s degree in related field (sciences, engineering or IT is preferred).

 

At Celestica, we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Accommodations are available on request for candidates throughout the hiring process. If you require an accommodation, we will work with you to meet your needs.   

 

 

COMPANY OVERVIEW:
Celestica (NYSE, TSX: CLS) is a US$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 27,000 employees throughout the Americas, Europe and Asia.

 


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