Equipment Validation Specialist

Mississauga, ON, CA, Canada

Job Description

Overview




The Instrument/Equipment Validation Specialist helps document and validate laboratory instrument software to meet

EMA

and

GxP

guidelines. The role ensures that all instrument systems are properly tested, documented, and compliant with

PPD IT

standards.

Main Responsibilities



Document and validate lab instrument software. Write requirements, test cases, and validation reports. Create system and data flow diagrams. Perform risk assessments for software and instruments. Work with lab, IT, and QA teams to ensure compliance.

Skills Required



Experience in

software or instrument validation

in a regulated environment. Strong

technical writing

and documentation skills. Knowledge of

GxP, EMA, or FDA

guidelines. Good

communication skills

and attention to detail.

Preferred



Familiarity with

LIMS, CDS

, or other lab software systems.

Understanding of

21 CFR Part 11

and

Annex 11

compliance.




Work model




We strive to provide flexibility wherever possible. Based on this role's business requirements, this is a remote position open to qualified applicants in the Canada. Regardless of your working arrangement, we are here to support a healthy work-life balance though our various wellbeing programs.


Note: The working arrangements for this role are accurate as of the date of posting. This may change based on the project you're engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.

We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.



Cognizant will only consider applicants for this position who are legally authorized to work in Canada without requiring employer sponsorship, now or at any time in the future.

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Job Detail

  • Job Id
    JD2972331
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Mississauga, ON, CA, Canada
  • Education
    Not mentioned