Validation Engineering Specialist II

Role overview

Schedule

• The stated work schedule is a 7.5-hour shift.
• Alternating or rotating shifts may be required.

Work environment

• The role is based in a GMP manufacturing environment and requires adherence to GMP safety standards.
• Office work and some personal protective equipment, such as safety glasses, gowning, gloves, a lab coat, or ear plugs, may be required.

Responsibilities

• Provide technical expertise and support to operations and Process Pharmacy.
• Compile, review, verify, and analyze data, including scanning executed batch records.
• Prepare and execute manufacturing and packaging process validation protocols for new and existing clients, and write reports.
• Complete risk assessments and review finished reports before final approval.
• Monitor production schedules and coordinate validation activities and requirements.
• Attend selected client meetings as the validation representative when required.
• Assist with investigations and special studies related to CPV process improvements.
• Support special projects and other validation teams as required.

Requirements and qualifications

• Bachelor’s degree and at least two years of validation experience in a GMP-regulated environment.
• Preferred fields of study include engineering, life sciences, chemistry, or a related technical field.
• Comprehensive knowledge of cGMP, FDA regulations, and industry standards such as ISO and GAMP5.
• Strong technical writing for validation documentation; proficiency in risk assessment and gap analysis.
• Experience independently managing validation projects; strong data analysis and problem-solving capabilities.
• Clear verbal and written communication, effective collaboration, and ability to manage multiple projects.
• Proficiency in Microsoft Office; knowledge of statistical analysis and process control methods.
• Minitab, Discoverant, and JMP proficiency is preferred; Power BI, Microsoft Fabric, AI, automation systems, and computer system validation experience are preferred.
• Experience with quality management systems and documentation and a record of completing projects on schedule in deadline-oriented environments.

Benefits

• Benefits listed include medical, dental, and vision coverage effective on day one, paid time off, designated paid holidays, a retirement savings plan, and tuition reimbursement.

Compensation

• The estimated annualized pay range in Ontario is $56,400 to $84,600.

Additional information

• Relocation assistance is not provided.
• Candidates must be legally authorized to work in Canada without sponsorship and able to pass a comprehensive background check.