Validation & Quality Engineering SME

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.