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Posted 3 days ago

Validation Engineering Specialist II

@ Thermo Fisher Scientific

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Whitby, Ontario

Full-time2+ years experience
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SIGNALS

Overview

Thermo Fisher Scientific is hiring a Validation Engineer II for its Whitby site, within the Continuous Process Verification team. The role covers validation protocols, reports and risk assessments for manufacturing and packaging processes in a GMP environment. The posting states a 7.5-hour shift, a salary range of $56,400 to $84,600, and that alternating or rotating shifts may be required.

Responsibilities:

  • Prepare and execute process and packaging validation protocols and reports
  • Compile, review and analyze batch and process data
  • Support operations and process pharmacy with validation expertise
  • Coordinate validation activities with production scheduling
  • Assist with investigations and CPV process improvement studies

Requirements summary:

  • Bachelor's degree plus 2 years of validation experience in GMP environment
  • Knowledge of cGMP, FDA regulations, ISO and GAMP5
  • Strong technical writing and risk assessment skills
  • Proficiency in Microsoft Office; Minitab, JMP, Power BI preferred
  • Experience with computer system validation preferred

Tools & skills

MinitabJMPDiscoverantPower BIMicrosoft FabricMicrosoft Office

Benefits mentioned

Health insuranceDentalVisionRetirement planPaid time offTuition support
Source and dates

Employer career site / ATS feed · phenom

Employer posting date
2026-11-03
First seen by our source
2026-11-04
Source record updated
2026-11-04

These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.

Job details

SeniorityMid level
DepartmentEngineering
Experience2+ years
Hours per week37.5
Travelair: none · ground: none
Work settingOffice, Plant or factory
PositionSitting and standing
Physical demandsphysical low · computer high
LanguagesEnglish
Background checkscriminal record
EducationBachelor’s degree (required)
Fields of studyEngineering, Life Sciences, Chemistry
Perks mentionedGenerous paid time off, Retirement plan, Tuition support

Summary and details written by AI from the posting; the employer’s posting is the authority.

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Thermo Fisher Scientific

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FieldValue
Open jobs on Jobsy58
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.

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