Validation Engineering Specialist II

Role overview

Responsibilities

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

Qualifications

• Bachelor’s degree and at least two years of validation experience in a GMP or regulated environment.
• Engineering, life sciences, chemistry, or another related technical field is preferred.
• Knowledge of cGMP, FDA regulations, and industry standards including ISO and GAMP5.
• Strong technical writing, risk assessment, gap analysis, data analysis, and problem-solving skills.
• Experience independently managing validation projects; clear communication and effective teamwork skills.
• Proficient in Microsoft Office; experience with quality systems, documentation, statistical analysis, and process control.
• Minitab, Discoverant, JMP, Power BI, Microsoft Fabric, AI, automation systems, and computer system validation are preferred.

Schedule

• Schedule is a 7.5-hour shift; alternating or rotating shifts may be required.

Workplace conditions

• Work is based at the Whitby manufacturing site and involves office conditions, GMP and safety standards, and some PPE use.

Compensation

• Estimated annualized pay range in Ontario is $56,400–$84,600.

Benefits

• Medical, dental, and vision benefits effective on day one, paid time off, designated holidays, a retirement savings plan, and tuition reimbursement.

Additional conditions