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Senior Manager, Computer System Validation

Date: Feb 5, 2021

Location: Toronto, CA

Company: Celestica International Inc.

Req ID: 68690 
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. 

 

The Senior Manager, Computer System Validation is responsible for the overall ownership, building and maintenance of the Computer System Validation and Compliance program for Celestica's Health Tech market segment. They will provide direct supervision to a team of Computer Systems Validation Analysts, as well as indirect through subordinate supervisors, and coordinate the activities accordingly. The incumbent will work with Global Quality, Enterprise Architecture and IT Platform Leads to execute validation. The incumbent will interact regularly with senior management or executive levels on matters concerning several functional areas, divisions and/or customers. They will maintain 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 and maintain 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 capabilities to improve overall quality, compliance and efficiency.
  • Develop and manage a high performance team of computer system validation analysts.

 

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 11/820, ISO13485 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, CA Validator, Equipment Control validation (PLC/SCADA), Network and Enterprise Content Management Systems and cloud/SaaS applications.
  • 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. 

 

Experience:

  • 10 years+ of computer validation experience in the medical device manufacturing industry or equivalent.

 
Education:

  • Bachelor's degree in sciences, engineering or IT preferred.

 
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. Accommodations are available upon 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$5.8 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 14 countries with over 24,000 employees throughout the Americas, Europe and Asia.


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