Validation Engineering Specialist III
3 days ago
We are seeking a highly skilled and experienced Validation Engineering Specialist III to join our team at Thermo Fisher Scientific. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our equipment and facilities processes, as well as reviewing and approving documents to ensure compliance with SOPs, client requirements, and Good Manufacturing Practices.
Key Responsibilities- Provide leadership and guidance to junior team members on validation requirements and protocols.
- Develop and execute process validation protocols and reports.
- Review and approve vendor documentation, change controls, and maintenance reports.
- Lead complex URS, FS, DS, HS, FAT, SAT document generation, review, and approval.
- Develop and lead project timelines, resources, and budgets for both minor and major projects.
- Lead risk assessment, HAZOP, FMEA's, and Validation plans for Equipment, Systems & Facilities.
- Attend client meetings as validation representative.
- Update assigned Master Validation Plans (MVPs) as per validation policy.
- Act as Subject Matter Expert during audit and regulatory inspections.
- Lead audit responses and assessment.
- Lead/facilitate technical investigations, deviations, and Corrective Action Preventative Action (CAPA) implementation.
- Lead with a continuous improvement attitude and actively participate in and initiate practical process improvement initiatives.
- Postsecondary diploma in Engineering, Science, or related field.
- Minimum 5 years of experience in validation within the pharmaceutical industry.
- Previous experience in project management.
- 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.
- Proficiency with Microsoft Office programs and Project Management tools.
- Proficiency with the English Language.
The 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.
-
Senior Validation Engineer
4 weeks ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeRole Overview: The Validation Engineering Specialist III is responsible for delivering specialized validation expertise essential for supporting operations and clients. This role involves completing protocols related to the validation of equipment and facility processes, as well as reviewing all finalized reports before they receive final approval. It...
-
Senior Validation Engineer
4 weeks ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeRole Overview: The Validation Engineering Specialist III will provide expert validation knowledge essential for supporting operations and client needs. This role involves completing protocols related to the validation of equipment and facility processes, along with reviewing all finalized reports before they receive final approval. It is crucial to ensure...
-
Validation Engineering Specialist III
6 days ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeJob SummaryWe are seeking a highly skilled and experienced Validation Engineer to join our team at Thermo Fisher Scientific. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our equipment and processes meets the highest standards of quality and regulatory compliance.Key ResponsibilitiesProvide leadership...
-
Validation Engineering Specialist III
1 week ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeJob SummaryWe are seeking a highly skilled and experienced Validation Engineer to join our team at Thermo Fisher Scientific. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our equipment and processes meets the highest standards of quality and regulatory compliance.Key ResponsibilitiesProvide leadership...
-
Validation Engineering Specialist II
2 days ago
Mississauga, Ontario, Canada ThermoFisher Scientific Full timeJob SummaryWe are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for providing specialized validation knowledge and information to support our operations and clients.Key ResponsibilitiesDesign and Implement Validation Strategies:...
-
Validation Engineering Specialist II
3 days ago
Mississauga, Ontario, Canada ThermoFisher Scientific Full timeJob SummaryWe are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for providing specialized validation knowledge and information to support our operations and clients.Key ResponsibilitiesDesign and Implement Validation Strategies:...
-
Validation Engineering Specialist II
2 days ago
Mississauga, Ontario, Canada ThermoFisher Scientific Full timeJob SummaryWe are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for providing specialized validation knowledge and information to support our operations and clients.Key ResponsibilitiesDesign and Implement Validation Strategies:...
-
Validation Engineering Specialist II
3 days ago
Mississauga, Ontario, Canada ThermoFisher Scientific Full timeValidation Specialist Validation Specialist Join our team at Patheon as a Validation Specialist and play a critical role in ensuring the quality and safety of our products. About the Role This is a challenging and rewarding opportunity for a highly skilled and detail-oriented individual to join our team and contribute to the success of our...
-
Validation Engineering Specialist II
1 week ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Validation Engineering Specialist to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our products and processes.Key ResponsibilitiesDesign and Implement Validation Strategies: Develop and execute validation...
-
Validation Engineering Specialist II
6 days ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Validation Engineering Specialist to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our products and processes.Key ResponsibilitiesDesign and Implement Validation Strategies: Develop and execute validation...
-
Validation Engineering Specialist II
2 days ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our products and processes.Key ResponsibilitiesDesign and Implement Validation Strategies: Develop and execute...
-
Validation Engineering Specialist II
2 days ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Validation Engineering Specialist II to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our products and processes.Key ResponsibilitiesDesign and Implement Validation Strategies: Develop and execute...
-
R&D Engineer III
1 hour ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleThe R&D Engineer III will play a key role in leading the development of our next generation steerable sheath for the franchise. This position will be responsible for developing new technology, products, equipment, and processes with minimal supervision.Key ResponsibilitiesSupport complex cutting-edge medical device systems through prototyping,...
-
Senior Validation Engineer
4 weeks ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeRole Overview: As a Senior Validation Engineer, you will leverage your specialized expertise in validation to support operational excellence and client satisfaction. Your primary responsibilities will include completing validation protocols for equipment and facility processes, as well as meticulously reviewing all final reports before approval. You...
-
Test Validation Engineer
4 weeks ago
Mississauga, Ontario, Canada Synopsys, Inc. Full timeJoin Our Innovative Team:Be a vital part of a dynamic team that pioneers and develops cutting-edge IP solutions, shaping the future of design. State-of-the-Art Testing Facilities:Our research and development testing laboratory is equipped with advanced high-speed testing apparatus, including Bit Error Rate Testers, Real-Time Oscilloscopes, Sampling Scopes,...
-
Process Engineer III
6 days ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleWe are seeking a highly skilled Process Engineer III to join our Advanced Technology team at Boston Scientific. The ideal candidate will have a strong background in mechanical engineering with a proven track record of designing manufacturing equipment.Your Responsibilities Will Include:Leading technology integration and knowledge transfer...
-
Process Engineer III
5 days ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleWe are seeking a highly skilled Process Engineer III to join our Advanced Technology team at Boston Scientific. The ideal candidate will have a strong background in mechanical engineering with a proven track record of designing manufacturing equipment.Your Responsibilities Will Include:Leading technology integration and knowledge transfer...
-
Lead Medical Device Development Engineer
3 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeBoston Scientific seeks a highly motivated R&D Engineer III to spearhead the development of innovative medical devices, focusing on next-generation steerable sheath technology within our esteemed franchise. In this pivotal role, you will contribute to the advancement of complex medical device systems through meticulous prototyping and rigorous testing. Your...
-
Validation Engineering Specialist I
3 weeks ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeWork ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionHow 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,...
-
Procurement Specialist III
4 weeks ago
Mississauga, Ontario, Canada Axelon Services Corporation Full timeProcurement Specialist IIILocation: RemoteDuration: Long-term ContractWork Shift: Standard Business HoursWork Arrangement: Flexible Hybrid ModelKey Responsibilities Include: Enhance operational efficiency for sourcing in Canada by identifying innovative opportunities to minimize expenses and improve productivity. Support the development and execution of...
