Computer System Validation Specialist II in Mississauga, Ontario

Job Description

As a part of the Thermo Fisher Scientific group, you’ll uncover significant work that makes a constructive impression on a worldwide scale. Be a part of our colleagues in bringing our Mission to life each single day to allow our prospects to make the world more healthy, cleaner and safer. We offer our world groups with the sources wanted to attain particular person profession objectives whereas serving to to take science a step past by growing options for among the world’s hardest challenges, like defending the setting, ensuring our meals is protected or serving to discover cures for most cancers.

How will you make an impression?

Assist all Pc Programs Validation (CSV) actions on the Canadian websites in addition to aiding on world CSV issues. Present specialised information and knowledge, which is immediately wanted to assist compliance of all pc and computerized methods with related regulatory. Tasks embody collaborating as a undertaking group member on pc system implementation tasks, each regionally and regionally, to guarantee that validation actions and life cycle methodology are included and documented appropriately throughout and after the undertaking in accordance with firm requirements and procedures. Key and important accountability shall be to characterize IT and High quality in discussing CSV technique and work carried out to regulatory and consumer auditors.

What’s going to you do?

• Put together and full protocols and write studies.

• Put together project-based documentation for computerized methods.

• Attend undertaking conferences.

• Present assist to High quality Operations/Enterprise or Undertaking administration/operations/ Pharmaceutics and Course of Know-how (PPT) as a technical professional.

• Put together protocols for non-computerized methods.

• Answerable for reviewing paperwork.

• Characterize IT for consumer/regulatory/inside audits (GMP/SOX).

• Conduct periodic critiques on consumer entry, audit trails and validated methods.

• Assist IT and High quality in discussing CSV technique and work carried out to regulatory and consumer auditors.

• Assist/handle compliance of Deviation Experiences (DRs) and Corrective Motion Preventative Actions (CAPAs) for the validation division.

• Replace Grasp Validation Plan (MVP) for Computerized Programs (as required).

• Keep a steady enchancment mindset and actively take part in and provoke sensible course of enchancment initiatives.

• Keep a protected working setting and report potential hazards.

• Carry out alternating and rotating shift work (as required).

How will you get right here?

Training:

BSc in Chemistry, Pharmacy, Engineering, Biotechnology, or associated discipline.

Expertise:

Minimal 2 years’ expertise in Pc System Validation.

Info Know-how experience and expertise with IT Infrastructure and IT Software implementations is an asset.

Equivalency:

Equal combos of training, coaching, and related work expertise could also be thought of.

Data, Abilities and Skills:

Aware of GMPs, GAMP4/5 and 21 CFR half 11. Wonderful written and oral abilities. Element oriented and arranged, with a excessive diploma of accuracy and thoroughness. Wonderful interpersonal abilities, communication and organizational abilities. Robust judgment, choice making and hassle taking pictures abilities. Capability to multi-task, assembly tight deadlines in a quick paced setting. Demonstrated pc proficiency with Microsoft Workplace packages. Proficiency with the English Language.

*Requirements and Expectations: *

Comply with all Environmental Well being & Security Insurance policies and Procedures. Work collaboratively with fellow group members, modelling constructive group ideas and partnering to fulfill undertaking and departmental targets. Perform all duties inside strict compliance to Patheon high quality methods Customary Working Procedures (SOPs) and Good Manufacturing Follow (GMP). Keep workspace in a clear and orderly trend.  Successfully have interaction in and cling to departmental methods to take care of a clean and environment friendly workflow (visible administration, scheduling methods, and many others.). Be consumer and affected person acutely aware always. Perceive Key Efficiency Indicators and try to enhance the efficiency of the group by figuring out areas for system enhancements and interact in downside fixing. Mannequin constructive pondering and is open to alter, motivating the group to adapt to shifts in priorities and new methods of working. Proactively determine areas for enchancment within the execution of procedures. Talk dangers to timelines in a proactive method.  Persistently strives to enhance abilities and information in associated discipline.  

Bodily Necessities:

Place requires peculiar ambulatory abilities and bodily coordination ample to maneuver about lab/lab workplace areas; capability to face, stroll, stoop, kneel, crouch periodically for extended intervals of time; manipulation (raise, carry, transfer) of sunshine to medium weights of 10-35 kilos; arm, hand and finger dexterity, together with capability to know and sort for extended intervals of time; visible acuity to make use of a keyboard, pc monitor, function tools, and skim supplies for extended intervals of time; capability to take a seat, attain with arms and arms, discuss, and listen to for extended intervals of time. Security glasses, security sneakers, lab coat, latex or comparable gloves, security apron, natural respirator sometimes.

Our Mission is to allow our prospects to make the world more healthy, cleaner and safer. Watch as our colleagues clarify 5 causes to work with us. As one world group of 100,000 colleagues, we share a typical set of values – Integrity, Depth, Innovation and Involvement – working collectively to speed up analysis, clear up advanced scientific challenges, drive technological innovation and assist sufferers in want. #StartYourStory at Thermo Fisher Scientific, the place various experiences, backgrounds and views are valued.

Apply at the moment! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Motion Employer and doesn’t discriminate on the idea of race, shade, faith, intercourse, sexual orientation, gender identification, nationwide origin, protected veteran standing, incapacity or every other legally protected standing.