Computer System Validation Specialist Ii

6 months ago

Mississauga, Canada Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**How will you make an impact?**

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.

**What will you do?**
- 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 a 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.
- Support/manage compliance of Deviation Reports (DRs) and Corrective Action Preventative Actions (CAPAs) for the validation department.
- Update Master Validation Plan (MVP) for Computerized Systems (as required).
- Maintain a continuous improvement mindset and actively participate in and initiate practical process improvement initiatives.
- Maintain a safe working environment and report potential hazards.
- Perform alternating and rotating shift work (as required).

**How will you get here?**

**Education**:
BSc in Chemistry, Pharmacy, Engineering, Biotechnology, or related field.

**Experience**:
Minimum 2 years’ experience in Computer System Validation.

Information Technology expertise and experience with IT Infrastructure and IT Application implementations is an asset.

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

**Knowledge, Skills and Abilities**:
Familiar with GMPs, GAMP4/5 and 21 CFR part 11. Excellent written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills, communication and organizational skills. Strong judgment, decision making and trouble shooting skills. Ability to multi-task, meeting tight deadlines in a fast paced environment. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

**Standards and Expectations**:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

**Physical Requirements**:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a

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