Computer Validation Specialist
2 weeks ago
How will you make an impact:
Provide specialized validation knowledge and information, which is directly required to support operations and clients. Complete all protocols related to the validation of equipment, processes and new products and review all finished reports prior to final approval. Ensure documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices.
What will you do:
- Design validation strategies for process, packaging, or cleaning validation.
- Prepare validation protocols and reports for process, packaging, bulk hold studies, shipping studies, cleaning validation and other additional studies.
- Monitor and coordinate manufacturing execution and provide trainings on validation protocols.
- Perform data collection, statistical analysis and prepare summary reports.
- Lead annual monitoring programs for cleaning and manage site cleaning matrix.
- Monitor and coordinate swab sampling activities for cleaning validation.
- Perform risk assessments for equipment, cleaning procedures and manufacturing processes.
- Prepare risk assessment, protocols, and reports for Continued Process Verification program.
- Conduct technical discussions with clients, project managers and other stakeholders to drive validation activities.
- Maintain a safe working environment and report potential hazards.
- Flexible to work extended hours or off-shifts based on project expectations (as required).
How will you get here:
Education: Bachelors/Master’s in chemistry, Pharmacy, Engineering, Biotechnology or related field.
Experience: Minimum 3-year experience in validation, process engineering or quality within the pharmaceutical/ biotechnology industry.
1 year experience conducting statistical analysis is an asset.
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-Tab 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 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 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.
-
Computer System Validation Specialist Ii
6 months ago
Mississauga, Canada Thermo Fisher Scientific Full timeAs 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...
-
Biotechnology Validation Specialist
6 hours ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeJob SummaryWe are seeking a skilled Biotechnology Validation Specialist to join our team at Thermo Fisher Scientific. As a key member of our operations, you will be responsible for providing specialized validation knowledge and information to support our clients and internal teams.The successful candidate will have a strong background in validation, process...
-
Computer Validation Specialist
3 days ago
Mississauga, Canada Vitalbio Full timeYou are self-motivated and have a high level of autonomy and enjoy working in a highly technical, fast-paced, multidisciplinary environment. You take ownership of a problem and seek additional information where sufficient input is lacking to proceed with testing and see the problem through to resolution. p>Work closely with the R&D and engineering teams to...
-
Quality Validation Specialist
6 months ago
Mississauga, Canada McKesson Full timeMcKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a...
-
Validation and Compliance Specialist
4 weeks ago
Mississauga, Ontario, Canada CPL Full timeWe are seeking a highly skilled Validation and Compliance Specialist to join our team at CPL, a leading Contract Development and Manufacturing Organization (CDMO) in the pharmaceutical industry.About UsCPL is passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and...
-
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeAbout the Role:We are seeking an experienced Validation Specialist III to join our team at Thermo Fisher Scientific.Job Description:The Validation Specialist III will be responsible for leading complex validation projects, providing technical expertise, and ensuring compliance with regulatory requirements.Key Responsibilities:Lead validation projects from...
-
Validation Specialist
6 months ago
Mississauga, Canada Contract Pharmaceuticals Full time**WHO WE ARE**: At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products. For more than 30 years CPL has partnered with the...
-
Validation Specialist
6 months ago
Mississauga, Canada CPL Full timeWHO WE ARE:At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products.For more than 30 years CPL has partnered with the world’s...
-
Design Validation Specialist
2 weeks ago
Mississauga, Ontario, Canada Synopsys, Inc. Full timeJoin a collaborative team of innovators at Synopsys, Inc. to develop cutting-edge IP solutions for the world's latest designs. Our R&D lab is equipped with state-of-the-art tools like 224Gb/s BERTs, 70GHz Oscilloscopes, and 67GHz Network analyzers. As a Design Validation Specialist, your key responsibilities will include working with a cross-functional team...
-
Computer Network Specialist
2 weeks ago
Mississauga, Ontario, Canada Dreams Network & Technology Inc Full timeJob DescriptionDreams Network & Technology Inc is seeking an experienced Computer Network Specialist to join our team.About the RoleThis permanent position offers a competitive salary of $60,000 - $80,000 per year, with opportunities for advancement and professional growth. As a Computer Network Specialist, you will be responsible for maintaining,...
-
Quality Assurance Validation Specialist
4 weeks ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeJob DescriptionWe are seeking a Quality Assurance Validation Specialist to join our team at Thermo Fisher Scientific.This role will involve designing validation strategies for process, packaging, or cleaning validation. The ideal candidate will have experience in completing all protocols related to the validation of equipment, processes and new products and...
-
Computer Network Specialist
2 weeks ago
Mississauga, Ontario, Canada Orkin Canada Corporation Full timeAbout Orkin Canada Corporation">We are a leading provider of pest control and management services in Canada. Our company is committed to delivering exceptional customer service and ensuring the health and safety of our customers.">Job Title: Computer Network Specialist">Salary: $55,000 - $65,000 per year">This role will be responsible for providing technical...
-
Software Development Specialist
4 weeks ago
Mississauga, Ontario, Canada LINTEX COMPUTER GROUP INC Full timeWe are seeking a highly skilled Software Development Specialist to join our team at LinTex Computer Group Inc. This role involves leading and coordinating teams of information systems professionals in the development of software and integrated information systems.About UsLinTex Computer Group Inc is a leading provider of innovative technology solutions. Our...
-
Electronics Validation Specialist
5 days ago
Mississauga, Ontario, Canada Synopsys Full timeAbout SynopsysAt Synopsys, we drive technology innovations that shape the way we live and connect. Our technology is at the forefront of the Era of Pervasive Intelligence, where smart tech and AI are seamlessly woven into daily life.Internship ExperienceYou'll work on real-world projects, gaining hands-on experience while collaborating with our passionate...
-
Computer Training and Education Specialist
4 weeks ago
Mississauga, Ontario, Canada CIMT College Full timeCIMT College is seeking a qualified Computer Training and Education Specialist to join our team. This role will involve providing training and instruction to students in a variety of computer-related subjects, including software applications, hardware, and network systems.The ideal candidate will have a strong background in computer science and education,...
-
Validation Engineering Specialist III
4 months ago
Mississauga, Canada Thermo Fisher Scientific Full timeProvide specialized validation knowledge and information, which is directly required to support operations and clients. Finish the protocols related to the validation of equipment andfacilities processes and review all finished reports prior to final approval. Ensure documents conform to all SOPs, client requirements and Good Manufacturing Practices. ...
-
Validation Engineering Specialist III
1 month ago
Mississauga, Canada Thermo Fisher Scientific Full timeJob Description Provide specialized validation knowledge and information, which is directly required to support operations and clients. Finish the protocols related to the validation of equipment and facilities processes and review all finished reports prior to final approval. Ensure documents conform to all SOPs, client requirements and Good Manufacturing...
-
Validation Engineering Specialist II
4 months ago
Mississauga, Canada Thermo Fisher Scientific Full timeHow will you make an impact: Provide specialized validation knowledge and information, which is directly required to support operations and clients. Complete all protocols related to the validation of equipment, processes and new products and review all finished reports prior to final approval. Ensure documents conform to all Patheon Standard Operating...
-
Validation Coordinator
6 months ago
Mississauga, Canada Sterigenics EO Canada Inc. Full timeJOB SUMMARY: Reporting to the Quality Assurance (QA) Manager, the Validation Coordinator acting as the facility technical representative is responsible for ensuring the requirements for ISO and QSRs are met and maintained for the facility and its customers. The Validation Coordinator provides management with information and data on all key aspects of each...
-
Hil Validation
6 months ago
Mississauga, Canada Emonics Full timeJob Type - HIL Validation Mississauga, Ontario, Canada - Key Words**:HIL & Opal-RT** **Job Description & Skill Requirement**: Scope of Work: - Work closely with global engineering teams to understand product requirements and ensure thorough testing from a business perspective - Define and develop test plans and document functional and integration test...
