Validation Engineering Specialist II – Equipment Engineering
Mississauga, Ontario, Canada · On-site
$56k–$85k/yr
Mid level$20B raised
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Validation Engineering Specialist II – Equipment Engineering
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$56k–$85k/yr
Full-time
bachelor degree
Posted 7d ago
~40 hrs/week
Responsibilities
The Validation Engineering Specialist II is responsible for preparing and executing validation protocols for equipment, processes, and cleaning procedures to ensure compliance with GMP and client standards. They also perform statistical data analysis, coordinate sampling activities, and provide training on validation protocols to support manufacturing operations.
Requirements
Candidates must possess a post-secondary diploma or degree in Chemistry, Engineering, or Science, with at least 2-3 years of experience in validation or process engineering within the pharmaceutical or biotech industry. Strong technical writing, organizational, and statistical analysis skills are required to manage documentation and project timelines effectively.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As a Engineer Specialist II you 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.
Essential Functions:
Prepare validation protocols and reports for process, packaging, or cleaning validation
Monitor and coordinate manufacturing execution and provide trainings on validation protocols
Perform data collection, statistical analysis and prepare summary reports
Monitor and coordinate swab sampling activities for cleaning validation
Prepare risk assessment, protocols and reports for Continued Process Verification program
Prepare protocols and reports for bulk hold studies, shipping studies and other additional studies as and when required
Interact 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)
REQUIRED QUALIFICATIONS
Education:
Minimum post-secondary diploma in Chemistry, Engineering, Science or related field. BSc in Chemistry or Engineering is an asset.
Experience:
Minimum 2-3 years experience in validation, process engineering or quality within the pharmaceutical/ biotechnological industry. Previous experience in statistical analysis preferred.
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.
Compensation
The estimated annualized pay range for this position in Ontario is $56,400.00–$84,600.00.
Related keywords
ValidationEquipment EngineeringGMPGood Manufacturing PracticesSOPProcess ValidationCleaning ValidationStatistical AnalysisRisk AssessmentContinued Process VerificationBulk Hold StudiesShipping StudiesPharmaceutical IndustryBiotechnological IndustryMini-TabMicrosoft Office
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
How many Manufacturing jobs are open in Mississauga, Canada right now?
There are currently 767 open manufacturing positions in Mississauga, Canada listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Mississauga, Canada?
Companies currently hiring include AtkinsRéalis, Thermo Fisher Scientific, MAD Elevator Inc, RTX, Eurofins Viracor, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Mississauga, Canada?
Yes — 135 of the 767 open manufacturing positions offer remote or hybrid work (16 remote, 119 hybrid).
How do I apply for Manufacturing jobs in Mississauga, Canada?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.