Senior Validation Analyst: High-Risk Projects

PCI TRGR Penn Pharmaceutical Services Ltd; Mississauga; Hybrid; CAD 75,000 - 85,000; Full time

Benefits offered by this job

Extended health benefits

RRSP with employer contributions

Paid time off

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd in Mississauga, Canada, seeks a Validation Analyst III to own high‑risk validation projects with minimal supervision. You will develop and execute validation protocols, support audits, manage change control, and coordinate across sites.

The role focuses on process/cleaning validation, HVAC/utility validation, and computer validation, ensuring compliance with cGMP, GxP, 21 CFR Part 11, and Annex 11.

Qualifications

• Associate's Degree/1-3 years related experience in a related field.
• College-level mathematical skills.
• Full professional proficiency in English (speaking, reading, writing).
• High reasoning and problem-solving abilities.

Responsibilities

• Manage validation activities to ensure compliance with government and customer requirements.
• Prepare validation protocols, statements, reports, and master validation plans for new projects and maintain validated processes.
• Coordinate multiple site approvals and maintain validation documentation with accuracy and closure.
• Prepare change control and validation history reports for audits and attend meetings as needed.
• Investigate deviations and implement corrective actions to close validation projects.

Skills

Math skills

Advanced computer skills

Communication skills

Problem solving

Education

Associate degree

Tools

Software proficiency

Job description

PCI TRGR Penn Pharmaceutical Services Ltd in Mississauga, Canada, seeks a Validation Analyst III to own high‑risk validation projects with minimal supervision. You will develop and execute validation protocols, support audits, manage change control, and coordinate across sites.

The role focuses on process/cleaning validation, HVAC/utility validation, and computer validation, ensuring compliance with cGMP, GxP, 21 CFR Part 11, and Annex 11.