- Prepare validation protocols, e.g. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for more complex equipment, facilities, and computer systems.
- Execute protocol, report deviations, and participate in deviation analysis and resolution.
- Participate in the data specifications and format review process.
- Maintain site computerized system inventory list.
- Conduct 21 CFR Part 11 assessment and Data Integrity assessment for computerized systems
- Provide technical expertise and support to Quality Operations/Business or Project management/operations/Pharmaceutics and Process Technology (PPT).
- Support special projects (as required)
- Maintain a safe working environment and report potential hazards.
-
Product Design Lead
4 days ago
Engineering Search Firm Inc Whitby, CanadaMust be able to work on site 3 Days per week. Must be a PR or Canadian Citizen: · Our multidisciplinary team consists of product, hardware, software and test specialists with a vast array of skills and competencies to meet the rigorous demands of the market. · We are currently re ...
-
Environmental Specialist
1 week ago
Gerdau Whitby, Canada**Date**:Feb 11, 2023 · **Location**: Whitby, Ontario, CA, L1N 5T1 · **Company**:Gerdau · **ENVIRONMENTAL SPECIALIST - WHITBY MILL** · **About the Job**: · Are you interested in pursuing a rewarding environmental career in the industrial sector? Gerdau is seeking an **Environment ...
-
Contract Administrator
6 days ago
GHD Whitby, CanadaBring your curiosity and determination to make a positive impact on the future of transport, and we'll help you go all the way **.** · **Who are we looking for?** · We seek a **Contract Administrator - Linear Infrastructure **to be based in the Greater Toronto Area offices with d ...
-
Construction Materials Laboratory Technician
1 week ago
WSP Whitby, Canada**The Opportunity**: · Our team is growing, and as a result we're adding a **Laboratory Technician **to join our group. As part of the **Construction Services, Materials Engineering and Laboratory Group **team in **Whitby **, you'll be responsible for driving forward our ambitiou ...
-
Operations & Maintenance Specialist
1 week ago
AECOM Whitby, CanadaCompany Description · At AECOM, we're delivering a better world. · We believe infrastructure creates opportunity for everyone. Whether it's improving your commute, keeping the lights on, providing access to clean water or transforming skylines, our work helps people and communiti ...
-
Field Service Technician
4 days ago
OPTI-TECH SCIENTIFIC INC. Whitby, CanadaDo you have a passion for delivering service excellence, with a background in electromechanical instrument service? Does the prospect of working within a team, while working with microscopes, sample preparation equipment, ovens, and furnaces sound intriguing? With your considerab ...
-
Deighton Experience Specialist
2 days ago
Deighton Associates Ltd. Whitby, Canada**Introduction**: · While being one of the companies leading the way in the development and implementation of asset management software worldwide, Deighton also provides career diversity in combination with challenging growth opportunities. Our core values include people first, c ...
-
Validation Engineering Specialist II
1 day ago
Thermo Fisher Scientific Whitby, Canada Full timeProvide specialized validation knowledge and information, which is directly needed to support operations and clients. Complete protocols and reports related to the validation of manufacturing processes, packaging processes (including serialization), Continues Process Verification ...
-
Validation Engineering Specialist I
6 days ago
Thermo Fisher Scientific Whitby, Canada Full time· Provides specialized validation knowledge and information, which is directly needed to support operations and clients. Complete protocols and reports related to the validation of manufacturing processes, packaging processes (including serialization), equipment qualification an ...
-
Electrical SAP Specialist
6 days ago
WorleyParsons Whitby, ON, CanadaJob Description - Electrical SAP Specialist (WHI0027) · Electrical SAP Specialist - WHI0027 · Construction Specialist Schedule · Full-time Employment Type : Employee · Over 120 office locations. · We're a global team of data scientists, consultants, construction workers and ...
-
Intermediate Environmental Consultant
5 days ago
Pggroup Whitby, ON, CanadaAdvancing people, environment, and business. Does that statement resonate with you? Do you enjoy working with an engaged team toward a common goal? Do you regularly question the norm and come up with creative solutions to problems? If you've answered yes to any of these questions ...
-
Senior Structural Engineer
4 days ago
ghd Whitby, ON, CanadaThere's no pledge more important than the one we make to look after our environment, and we're committed to helping you do exactly that. · Our Ontario EDO (Engineering Design Organization) is looking for a dynamic and motivated individual to take on the role of Senior Structural ...
-
Intermediate Project Engineer
1 day ago
GHD Whitby, CanadaBring your curiosity and determination to make a positive impact on the future of transport, and we'll help you go all the way. · Join our team of globally connected specialists to help solve complex transport challenges and experience ground-breaking projects from idea to deli ...
-
Interface Manager
1 day ago
GHD Whitby, CanadaBring your curiosity and determination to make a positive impact on the future of transport, and we'll help you go all the way. · Join our team of globally connected specialists to help solve complex transport challenges and experience groundbreaking projects from idea to delive ...
-
Project Manager
1 day ago
GHD Whitby, CanadaThere's no pledge more important than the one we make to look after our environment, and we're committed to helping you do exactly that · Join us as we strive to ensure a sustainable future for our communities and the world we live in. · Become part of our global network of ski ...
-
Project Manager, Senior
1 day ago
GHD Whitby, CanadaThere's no pledge more important than the one we make to look after our environment, and we're committed to helping you do exactly that · Join us as we strive to ensure a sustainable future for our communities and the world we live in. · Become part of our global network of ski ...
-
Electrical Engineer
1 day ago
GHD Whitby, CanadaThere's no pledge more important than the one we make to look after our environment, and we're committed to helping you do exactly that. · Who are we looking for? · We're looking for an Electrical Engineer (Intermediate) to join one of our GTA or Waterloo offices. To be succes ...
-
Senior Civil3D Modelling Technician
1 day ago
GHD Whitby, CanadaWe're looking for a Senior Civil3D Modelling Technician to join our growing Canadian Operations. To be successful, you must have a minimum of 8-10 years of civil design (Civil3D) experience in rail, stations, and/or transportation facilities projects including multi-modal corrid ...
-
Senior 3D Estimator
1 day ago
GHD Whitby, CanadaBring your curiosity and determination to make a positive impact on the future of transport, and we'll help you go all the way. · Join our team of globally connected specialists to help solve complex transport challenges and experience groundbreaking projects from idea to delive ...
-
quality specialist
4 days ago
GERDAU S.A. Whitby, CanadaQUALITY SPECIALIST, METALLURGY - WHITBY MILL · Key Areas of Responsibility: · Conduct studies into the properties and production of new steels considering technical and standard requirements, properties and materials characteristics, process capabilities and statistical tools t ...
Validation Engineering Specialist - Whitby, Canada - Thermo Fisher Scientific
Description
Job Description
This Co-Op position is a minimum of 12 months and will run from May 2024 through April 2025
Summary:
Provides specialized validation knowledge and information, which is directly required to support operations and clients. Completes all protocols related to the validation of equipment, processes, and new products and reviews all finished reports prior to final approval. Ensures documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements, and Good Manufacturing Practices.
Essential Functions:
REQUIRED QUALIFICATIONS
Education:
A high school diploma/General Educational Development (GED) Certificate is required
Currently enrolled in a B.Sc. Program in Computer Science, Mechanical Engineering, Life Science, or related fields
Experience:
Previous experience in a validation or science related environment.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Strong 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. Mini-T and data analysis knowledge an asset. 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 SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order 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. Models 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 keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
