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- Full-time
Knowledge of diverse, culturally safe and representative workforce
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Minimum of two (2) years’ experience in the human/social services field.
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Claims Representative II, Special Lines
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Manager, Project Controls (14009)
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Business development experience in the financial advisory services field

Thermo Fisher Scientific

Validation Engineering Specialist II

Whitby, ON, Canada

Full-time

Apply About employer

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Job details

Job type: Full-time
Experience: Bachelor's degree plus 2 years of validation experience in GMP/regulated environment
Posting language: English
Posted: Nov 4, 2026

Original job description

Work Schedule

7 1/2 hr shift

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

Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility.

Discover Impactful Work:
Join our collaborative team as a Validation Engineer II at Thermo Fisher Scientific within the Continuous Process Verification (CPV) team, where you'll contribute to global healthcare and scientific advancement. In this role, you'll be responsible for providing specialized validation knowledge and information, which is directly required to support operations and clients. This role main focus will be on Continuous Process Verification (CPV). Compile data and scan of executed batch records, completes risk assessments, protocols and reports related to the validation of manufacturing processes, packaging processes and reviews all finished reports prior to final approval.

Day in the Life:

Responsible for technical expertise and support to operations/Process Pharmacy.

Compiles, reviews/verifies and analyzes data

Prepares and executes process/package validation protocols (new and existing clients) and writing reports.

Monitors the production scheduling and coordinating validation activities/requirements

Attends selected client meetings as validation representative (as required)

Assists in execution of investigations and special studies related to CPV process improvements

Supports special projects and other validation teams (as required)

May be essential to perform alternating or rotating shifts (as required)

Keys to Success:

Bachelor's degree plus 2 years of validation experience in GMP/regulated environment
Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)
Strong technical writing skills for validation documentation
Proficiency in risk assessment and gap analysis
Experience managing validation projects independently
Strong data analysis and problem-solving capabilities
Clear verbal and written communication skills
Proficient in Microsoft Office applications

Proficiency preferred in Minitab, Discoverant, JMP

Proficiency preferred in PowerBi, Microsoft Fabric and A.I
Experience with automation systems and computer system validation preferred
Effective interpersonal skills for team collaboration
Ability to manage multiple projects
Experience with quality management systems and documentation
Knowledge of statistical analysis and process control methods
Consistent record of completing projects on schedule in a deadline-oriented environment

Excellent Benefits

· Benefits & Total Rewards | Thermo Fisher Scientific

· Medical, Dental, & Vision benefits-effective Day 1

· Paid Time Off & Designated Paid Holidays

· Retirement Savings Plan

· Tuition Reimbursement

OTHER

· Relocation assistance is NOT provided

· Must be legally authorized to work in Canada now or in the future, without sponsorship

· Must be able to pass a comprehensive background check

Compensation

The estimated annualized pay range for this position in Ontario is $56,400.00–$84,600.00.

Apply About employer

More about this job

Responsibilities

The Validation Engineer II will provide specialized validation expertise to support manufacturing and packaging processes, with a primary focus on Continuous Process Verification (CPV). Responsibilities include compiling and analyzing data, executing validation protocols, and preparing technical reports to ensure compliance with GMP and regulatory standards.

Requirements

Candidates must hold a bachelor's degree in Engineering, Life Sciences, or Chemistry, along with at least 2 years of validation experience in a regulated environment. Proficiency in cGMP, FDA regulations, and strong technical writing and data analysis skills are required.

Skills

Validation
GMP
Technical writing
Risk assessment
Gap analysis
Data analysis
Problem-solving
Microsoft Office
Minitab
Discoverant
JMP
PowerBi
Microsoft Fabric
Automation systems
Computer system validation

Benefits

Medical benefits
Dental benefits
Vision benefits
Paid time off
Designated paid holidays
Retirement savings plan
Tuition reimbursement

Visa sponsorship

Not detected in the job text

Keywords

Validation Engineering
GMP
CPV
Pharmaceutical Manufacturing
FDA Regulations
ISO
GAMP5
Technical Writing
Risk Assessment
Gap Analysis
Data Analysis
Minitab
Discoverant
JMP
PowerBi
Microsoft Fabric
Automation Systems
Computer System Validation
Quality Management Systems
Statistical Analysis
Process Control
Batch Records
Engineering
Life Sciences
Chemistry
Compliance
Documentation
Project Management
Thermo Fisher Scientific

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