Pharma Qualification Engineer: Quality & Compliance Lead

Select Human Resources n.v; Town of Belgium (WI); Hybrid; USD 70,000 - 105,000; Full time

Job summary

Select Projects is seeking a Qualification Engineer for an assignment with our client in Geel. You will support the engineering team in qualifying equipment throughout its lifecycle, ensuring accuracy and timely approvals.

The role emphasizes reviewing qualification and validation documents, supporting new or updated systems, and providing guidance on cGMP compliance during qualification activities in a pharmaceutical setting. Strong collaboration with QA is essential.

Qualifications

• Experience reviewing qualification and validation documents (SOPs, URS, risk assessments, test plans, scripts, change controls, CAPAs).
• Familiarity with cGMP and quality systems in pharmaceutical environments.
• Ability to communicate status updates to QA teams and support deviations.

Responsibilities

• Reviewing and approving qualification and validation documents (SOPs, URS, risk assessments, test plans, scripts, change controls, CAPAs, etc.).
• Supporting engineering teams with introduction of new or updated systems and processes.
• Providing advice on cGMP aspects and compliance during qualification and validation activities.
• Following up on deviations and communicating status updates to QA teams.

Skills

Qualification documents

Validation documents

SOPs

URS

Risk assessments

Test plans

Scripts

Change controls

CAPAs

Job description

Select Projects is seeking a Qualification Engineer for an assignment with our client in Geel. You will support the engineering team in qualifying equipment throughout its lifecycle, ensuring accuracy and timely approvals.

The role emphasizes reviewing qualification and validation documents, supporting new or updated systems, and providing guidance on cGMP compliance during qualification activities in a pharmaceutical setting. Strong collaboration with QA is essential.