Validation Engineering Specialist II

Role overview

Schedule and conditions

• Work schedule is a 7.5-hour shift; alternating or rotating shifts may be required.
• Work involves GMP safety standards, an office environment, and some required personal protective equipment.

Responsibilities

• Provide technical expertise and support to operations and Process Pharmacy.
• Compile, review, verify, and analyze data, including scans of executed batch records.
• Prepare and execute process and packaging validation protocols for new and existing clients and write reports.
• Complete validation risk assessments, protocols, and reports; 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.

Qualifications and skills

• Bachelor’s degree plus at least 2 years of validation experience in a GMP or regulated environment.
• Preferred fields of study: engineering, life sciences, chemistry, or a related technical field.
• Comprehensive knowledge of cGMP, FDA regulations, and industry standards including ISO and GAMP5.
• Strong technical writing; proficiency in risk assessment, gap analysis, data analysis, and problem-solving.
• Experience managing validation projects independently; ability to manage multiple projects and meet deadlines.
• Clear verbal and written communication and effective interpersonal skills for team collaboration.
• Proficiency in Microsoft Office; experience with quality management systems and documentation.
• Knowledge of statistical analysis and process control methods.
• Minitab, Discoverant, JMP, Power BI, Microsoft Fabric, AI, automation systems, and computer system validation are preferred.

Benefits

• Medical, dental, and vision benefits effective on day one; paid time off and designated holidays.
• Retirement savings plan and tuition reimbursement.
• Relocation assistance is not provided.

Compensation

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

Other conditions

• Candidates must be legally authorized to work in Canada now or in the future without sponsorship and must pass a comprehensive background check.