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ALGOBRAINZ
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- Contract
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ALGOBRAINZ

Validation & Quality Engineering SME

ON, Canada
Ontario, Canada, Canada

Contract

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Job details

Job type: Contract
Apply by: Nov 27, 2026
Experience: Experience: 6+ years
Posting language: English
Posted: Oct 28, 2026

Original job description

Title: Validation & Quality Engineering SME

Industry: Pharmaceutical / Life Sciences

Location: Canada

Experience: 6+ years

Job Summary:

We are seeking an experienced Validation & Quality Engineering Subject Matter Expert (SME) to support pharmaceutical quality remediation and validation improvement initiatives in Canada.

The ideal candidate will have strong hands-on experience in cleaning validation, equipment qualification, validation documentation, and quality engineering within a regulated pharmaceutical manufacturing environment.

In this role, you will help strengthen the cleaning validation program, assess facility and equipment readiness, support engineering remediation activities, and ensure that validation processes meet applicable Good Manufacturing Practice (GMP) requirements. You will work closely with Quality Assurance, Engineering, Manufacturing, and Validation teams to address compliance gaps and implement sustainable improvements.

Roles and Responsibilities

Assess the existing cleaning validation program, identify compliance gaps, and develop a practical remediation strategy.
Establish cleaning validation approaches, including equipment cleanability assessments, worst-case product selection, sampling locations, and scientifically justified acceptance limits.
Support the development and implementation of health-based exposure limits (HBEL) and permitted daily exposure (PDE)-based cleaning limits, where applicable.
Prepare and review cleaning validation protocols, support execution activities, evaluate results, and develop final validation reports.
Establish periodic review requirements to ensure cleaning validation remains effective and aligned with current manufacturing processes.
Assess the condition and GMP readiness of manufacturing facilities, production equipment, and associated utilities.
Identify equipment and facility deficiencies and prioritize maintenance and remediation activities based on product quality, patient safety, and compliance risks.
Define cleaning verification, clean-down documentation, equipment release requirements, and room readiness criteria before manufacturing activities begin.
Review equipment qualification and validation documents, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
Assess cross-contamination risks in multi-product manufacturing facilities and recommend appropriate cleaning and control strategies.
Apply quality risk management principles, including ICH Q9, to support risk-based decisions and remediation priorities.
Work with cross-functional teams to resolve validation and engineering issues, maintain documentation quality, and support inspection readiness.
Track remediation progress, identify potential compliance risks, and provide regular updates on project milestones and outstanding actions.

Preferred Qualifications

Minimum 5 years of hands-on experience in cleaning validation strategy and execution within pharmaceutical manufacturing.
At least 5 years of experience in validation or quality engineering, including the preparation, assessment, and review of validation protocols and reports.
Strong knowledge of equipment qualification, including IQ, OQ, and PQ.
Experience with pharmaceutical change control, risk assessments, and quality risk management principles, particularly ICH Q9.
Experience working in multi-product pharmaceutical manufacturing facilities, particularly solid oral dosage operations.
Knowledge of HBEL/PDE-based cleaning limits and toxicological risk assessments.
Experience working with QA, Engineering, Manufacturing, and Validation teams on quality improvement initiatives.

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More about this job

Responsibilities

Assess and improve cleaning validation programs, evaluate facility and equipment readiness, and support qualification, remediation, and GMP compliance activities. Coordinate with Quality Assurance, Engineering, Manufacturing, and Validation teams to address risks, maintain documentation, track remediation, and support inspection readiness.

Requirements

Requires at least five years of hands-on cleaning validation experience and at least five years in validation or quality engineering, including protocol and report review. Candidates should know equipment qualification, GMP, ICH Q9 risk management, change control, and preferably multi-product manufacturing and HBEL/PDE-based cleaning limits.

Skills

Cleaning Validation
Equipment Qualification
Validation Documentation
Quality Engineering
GMP Compliance
HBEL/PDE-Based Cleaning Limits
Risk Assessment
ICH Q9
Cross-Contamination Risk Assessment
Change Control
IQ/OQ/PQ
Pharmaceutical Manufacturing
Validation Protocols and Reports
Remediation Planning
Inspection Readiness

Visa sponsorship

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Keywords

Pharmaceutical
Life Sciences
Good Manufacturing Practice
Cleaning Validation
Equipment Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Validation Protocols
Validation Reports
Health-Based Exposure Limits
Permitted Daily Exposure
Toxicological Risk Assessment
Cross-Contamination
Quality Risk Management
ICH Q9
Change Control
GMP Readiness
Facility Readiness
Equipment Readiness
Cleaning Verification
Equipment Release
Room Readiness
Remediation
Inspection Readiness
Solid Oral Dosage
Multi-Product Manufacturing
Quality Assurance
Engineering
Manufacturing

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