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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
