Computer System Validation Specialist II

ThermoFisher Scientific; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading scientific research company in Peel Region, Mississauga is seeking an expert to support Computer Systems Validation activities. The ideal candidate should have a background in Chemistry or Engineering, with a minimum of 3 years in Computer System Validation and IT. Key responsibilities include preparing protocols, supporting audits, and documenting compliance activities. Join a team dedicated to maintaining safety and regulatory standards.

Qualifications

• Minimum 3 years experience in Computer System Validation.
• Minimum 3 years Information Technology expertise.
• Equivalent combinations of education and experience may be considered.

Responsibilities

• Participate as a project team member on computer system implementation projects.
• Prepare and complete protocols and write reports.
• Support and lead compliance of Deviation Reports (DRs) and Corrective Action Preventative Actions (CAPAs).

Skills

Computer System Validation

IT Infrastructure expertise

Good Manufacturing Practices (GMP)

Education

Post secondary diploma in Chemistry, Engineering, Science

BSc in Chemistry or Engineering

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Summary:

Support all Computer Systems Validation (CSV) activities at the Canadian sites as well as assisting on global CSV matters. Provide specialized knowledge and information, which is directly needed to support compliance of all computer and computerized systems with relevant regulatory. Responsibilities include participating as a project team member on computer system implementation projects, both locally and regionally, to assure that validation activities and life cycle methodology are incorporated and documented appropriately during and after the project in accordance with company standards and procedures. Key and critical responsibility will be to represent IT and Quality in discussing CSV strategy and work performed to regulatory and client auditors.

Essential Functions:

Prepare and complete protocols and write reports.

Prepare project-based documentation for computerized systems

Attend project meetings.

Provide support to Quality Operations/Business or Project management/ Operations/Pharmaceutics and Process Technology (PPT) as technical expert.

Prepare protocols for non-computerized systems.

Responsible for reviewing documents.

Represent IT for client/regulatory/internal audits (GMP/SOX).

Conduct periodic reviews on user access, audit trails and validated systems.

Support IT and Quality in discussing CSV strategy and work performed to regulatory and client

auditors.

Generate, review and approve URS documents.

Support and lead compliance of Deviation Reports (DRs) and Corrective Action Preventative Actions (CAPAs) for the validation department.

Update Master Validation Plan (MVP) for Computerized Systems

Maintain a continuous improvement attitude by actively participating in and initiating practical process improvements.

Maintain a safe working environment and report potential hazards.

Perform alternating and rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:

Post secondary diploma in Chemistry, Engineering, Science, or related field. BSc in Chemistry or Engineering is an asset.

Experience:

Minimum 3 years experience in Computer System Validation.

Minimum 3 years Information Technology expertise and experience with IT Infrastructure and IT

Application implementations.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.