Field Validation Specialist - cGMP & Site Testing

Grifols; Toronto; On-site; CAD 70,000 - 100,000; Full time

Job summary

Grifols Canada is seeking a Field Validation Specialist to ensure cGMP adherence and quality systems across validation protocols at plasma donor centers. The role requires site travel to perform Operational Qualification and Performance Qualification testing.

The candidate will interact with Donor Center and Field Quality teams, assist in maintaining regulatory-aligned validation approaches, and help compile validation documentation and reports.

Qualifications

• Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and SOPs.
• Excellent quantitative and analytical skills.
• Excellent oral and written communication skills.
• Strong critical thinking and problem-solving skills.
• Ability to identify errors and provide corrective action.
• Ability to work with others in a team environment.

Responsibilities

• Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing for timely and documented approval prior to implementation.
• Assists in ensuring validation approaches are current to regulatory expectations and standards.
• Executes freezer installation, operational, and performance qualifications on-site at donor centers and affiliated locations.
• Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries.
• Communicates with Field Quality/Operations and other personnel on Donor Center compliance and cGMP issues.
• Writes test cases to validate critical control points, user requirements, and functional designs; executes test cases as needed; prepares validation reports; ensures milestones and timelines are met.
• Prepares validation equipment for Donor Center use and evaluation; assists in identifying actions to add or revalidate processes and equipment; tracks failures and calibration due dates.

Skills

cGMP knowledge

Analytical skills

Communication skills

Critical thinking

Team collaboration

MS Office

Education

Bachelor’s degree in a related field

Tools

MS Office

Job description

Grifols Canada is seeking a Field Validation Specialist to ensure cGMP adherence and quality systems across validation protocols at plasma donor centers. The role requires site travel to perform Operational Qualification and Performance Qualification testing.

The candidate will interact with Donor Center and Field Quality teams, assist in maintaining regulatory-aligned validation approaches, and help compile validation documentation and reports.