Oakville, On Engineer ii validation Jobs – 13 Openings This Week

Manufacturing Engineer II
VitalBio —Oakville, ON
- $100,000–$110,000 a year
- Inventory management
- Project management
- Bachelor's
Quick apply
Validation Engineering Specialist II – Equipment Engineering
Thermo Fisher Scientific —Mississauga, ON
- $56,400–$84,600 a year
- Full-time
- Computer literacy
- Engineering
- English
18h
Scientist - II
VitalBio —Oakville, ON
- $80,000–$95,000 a year
- Inventory management
- Laboratory experience
- Maintenance
Quick apply
14d
Sr. Software Developer Quality Engineer- Medical Devices
Capgemini —Burlington, ON
- Hybrid work
- Computer Science
- Engineering
- Analysis skills
- Disability insurance
- Dental care
Chemist II - Compendial Testing
Element Materials Technology —Mississauga, ON
- $26.40–$28.80 an hour
- Math
- Bachelor's
- Time management
5d
Sr. Software Developer Quality Engineer- Medical Devices
Capgemini Sogeti —Burlington, ON
- Hybrid work
- Computer Science
- Engineering
- Analysis skills
- Disability insurance
- Dental care
Chemist II - E&L and Pharma Chemistry
Element Materials Technology —Mississauga, ON
- $26.40–$28.80 an hour
- Math
- Bachelor's
- Time management
5d

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Validation Engineering Specialist II – Equipment Engineering
Thermo Fisher Scientific —Mississauga, ON
Prepare risk assessment, protocols and reports for Continued Process Verification program. Prepare protocols and reports for bulk hold studies, shipping studies…
$56,400–$84,600 a year
18h

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Manufacturing Engineer II

VitalBio
Oakville, ON

Quick apply

Job details

Permanent
$100,000–$110,000 a year

Qualifications

Six Sigma Certification
Defect resolution root cause analysis
Inventory management
Statistical Process Control
Continuous improvement standards implementation
GMP
Minitab
Six Sigma
Project management
Bachelor's
Decision making
Risk management
Data analytics
Industrial or manufacturing engineering experience
Manufacturing
Root cause analysis
Manufacturing engineering
Cross-functional collaboration
Leadership
Project management experience
Communication skills
Lean manufacturing
ISO 13485
Cross-functional communication

Full job description

About you:

You are a hands-on technical problem solver with deep experience in transferring products from R&D to manufacturing in a cGMP-regulated environment. You thrive where engineering, automation, and operations meet: designing, scaling, and optimizing manufacturing assembly processes that ensure quality, reliability, and efficiency. You approach each challenge with a disciplined, data-driven mindset, excel at cross-functional teamwork, and are energized by continuous improvement and innovation. You’re ready to contribute your expertise to help Vital Bio bring diagnostics to life.

What you'll do:

Lead the transfer of new products and manufacturing processes from R&D engineering and assay development into a cGMP manufacturing environment.
Design, develop, document and implement robust manufacturing processes and scale-up activities for consumable assemblies (reagents with molded plastic components) and diagnostic instruments.
Provide DFx feedback to ensure manufacturability, scalability, and cost effectiveness of new designs.
Define and evaluate different assembly strategies, identify automation opportunities, and maintain cost-effective, high-quality, repeatable operations; including Make/Buy decisions and third-party transfers.
Develop process flow maps, optimize assembly sequences applying lean principles, and recommend new processes/equipment.
Serve as the manufacturing subject matter expert, identifying risks and mitigation strategies related to process steps, raw materials, and product performance (and their interactions) throughout tech transfer.
Collaborate cross functionally with R&D engineering, assay development, manufacturing and supply chain teams to ensure effective inventory management and material supply for verification and validation needs.
Establish and maintain manufacturing controls and documentation, including SOPs, work instructions, and acceptance plans, in compliance with ISO 13485, FDA 21 CFR 820, and cGMP.
Plan and execute comprehensive validation protocols for equipment, facilities, and processes (IQ, OQ, PQ and TMV).
Perform root cause analysis for manufacturing failures with cross-functional teams and implement process improvements.

What you need:

Bachelor’s degree in a STEM discipline.
5+ years’ significant manufacturing engineering or related operational experience in diagnostics or similar fields combining biologicals/reagents with injection-molded plastics.
Proven ability to apply critical thinking, analytical reasoning, and experimental design to solve complex manufacturing problems.
Working knowledge of tech transfer, cGMP processes, process validation / /qualification (IQ/OQ/PQ/TMV), and regulated manufacturing environments.
Strong familiarity with manufacturing of reagents, consumables, and instruments for IVDs, tech transfer, cGMP processes, and validation/qualification requirements.
Experience collaborating with cross-functional teams and managing multiple projects simultaneously.
Experience with statistical process controls (SPC), design of experiments (DOE), and data analysis (Minitab, JMP, Excel).
Excellent communication skills and sharp attention to detail.
Highly organized with a proactive, solutions-oriented approach.

Bonus points for:

Six Sigma and/or Lean certification, with practical experience using these tools for process improvement.
Prior experience with high-volume automated assembly and global IVD manufacturing regulations.
Experience in scaling up manufacturing operations from pilot scale to full production mode.
Project management experience and leadership of project teams.
An appreciation for puns and a willingness to pitch in wherever needed!

Why Join Us?

At Vital Bio, you will:

Take a critical role in building and scaling manufacturing operations for novel diagnostics, impacting global healthcare systems.
Work alongside passionate problem-solvers in a culture that values curiosity, teamwork, and innovation.
Own your contributions on projects with meaningful, real-world outcomes.
Grow your skills in a supportive, dynamic environment that believes fun and excellence go hand-in-hand.

About Vital

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance

The salary range for this position is $100,000-$110,000 annually. Compensation will be determined based on the individual's demonstrated experience.

Quick apply

Refine Your Search

engineer ii validation jobs in oakville, on

Manufacturing Engineer II

Validation Engineering Specialist II – Equipment Engineering

Scientist - II

Sr. Software Developer Quality Engineer- Medical Devices

Chemist II - Compendial Testing