Validation Engineering Specialist II

ThermoFisher Scientific; Whitby; On-site; CAD 56,000 - 85,000; Full time

Benefits offered by this job

Medical benefits

PTO and holidays

Retirement plan

Tuition reimbursement

Job summary

Thermo Fisher Scientific in Whitby, Ontario, is seeking a Validation Engineer II to support Continuous Process Verification (CPV) across manufacturing and packaging processes. You will compile data, assess risk, write validation protocols and final reports, and help ensure compliance with GMP and regulatory standards.

The role requires a Bachelor’s degree with 2 years of validation experience, strong technical writing, and proficiency in data analysis tools.

Qualifications

• Bachelor's degree plus 2 years of validation experience in GMP/regulated environment.
• Strong knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5).
• Experience with validation projects and writing reports.

Responsibilities

• Provide technical expertise and support to operations/Process Pharmacy.
• Compile, review and analyze validation data and reports.
• Prepare and execute validation protocols and write final reports.
• Monitor production scheduling and coordinate validation activities.
• Attend client meetings as validation representative as required.
• Assist in investigations and studies related to CPV process improvements.
• Support other validation teams and special projects as required.

Skills

Validation

CPV

GMP

Data analysis

Risk assessment

Technical writing

Project management

Microsoft Office

Minitab

Discoverant

JMP

Power BI

Education

Bachelor's degree

2 years validation experience in GMP/regulatory environment

Tools

Microsoft Fabric

A.I

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 (https://www.patheon.com/us/en/our-capabilities/small-molecule/oral-solid-dose.html) for a full range of conventional dosage forms (https://www.patheon.com/us/en/our-capabilities/small-molecule/oral-solid-dose.html) 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 (https://jobs.thermofisher.com/global/en/total-rewards)
• 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.