Celestica Inc.

Director, Computer System Validation (BB-900D4)

Found in: Talent CA

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. Summary:The Director, Computer System Validation is responsible for the overall ownership, building and maintenance of the Compliance program for Celestica's Health Tech (HT) market segment. They will provide direct and indirect supervision to a team of CSV Analysts and coordinate the activities accordingly. The incumbent will work with Global Quality, Enterprise Architecture and IT Platform Leads to execute validation, as well as interact regularly with senior management 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: Owns and manages the CSV and compliance program for Celestica's HT market segment Develop and manage a high performance team of computer system validation analysts. Management and accountability of Site Validation activities Program management of the IT Compliance deployment program including chairing and leading the HT Steering Committee Ownership of the relationship with key HT IT suppliers/partners Partner with Global Quality to ensure requirements are met for Good Manufactured Product according to FDA 21CFR Part 11/820, ISO13485 and other applicable regulations Acts as a change agent to educate and embed HT Validation in all support functions and teams Work with Enterprise Architecture and IT Platform leads to execute validation and change control processes impacting HT products Partner with the Director of HT Quality to develop and implement strategies for continuous improvement in IT Compliance Work with executive management to determine acceptable levels of risk for the organization. Create and maintain Celestica HT Validation policies, procedures, and controls Evaluate general and specific training needs; deliver training to support the control environment & associated control framework; communicate governance & compliance objectives, fostering a compliance & risk aware culture Accountability and ownership of all HT IT compliance execution activities including schedules, costs/budgets and strategy for validation Negotiate with, escalate and drive deployment and adoption of IT Compliance activities, processes and standards at senior levels International business travel, approx 25% Knowledge/Skills/Competencies: Experience in validation of Computer Systems, investigations, and change control in a medical device manufacturing environment Good understanding of GMPs 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, 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 SMEs, IT team members as well as business users across the globe Strong emphasis on customer service and interpersonal skills Effective team player and ability to work in a rapidly changing environment 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 Excellent analytical, negotiation, problem resolution and presentation skills Advanced knowledge of project management Advanced knowledge of architecture and solution integration Mastery level of knowledge in business partnering and organizational change management Mastery in IT Risk Management Knowledge of IT Compliance Standards and best practices Ability to effectively lead, manage, train and motivate a global group of employees to achieve high performance levels Experience & Education: 12+ years of computer validation experience in the medical device manufacturing industry or equivalent. 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. Job Segment: Developer, Engineer, ERP, Cloud, SAP, Technology, Engineering

calendar_today5 days ago


location_on Toronto, Canada

work Celestica Inc.

I expressly authorise the Terms and Conditions

Similar jobs