Validation Engineer

QA Resources Ltd; Cork; Hybrid; EUR 54,000 - 80,000; Full time

Job summary

QA Resources Ltd in Cork is recruiting a Validation Engineer for a leading pharma company on a 9-month contract. The role focuses on validation of manufacturing equipment and associated test activities.

You will generate and review Validation Plans, FAT/SAT/FTs, and PQs, liaise with cross-functional teams and vendors, and ensure compliance with quality by design principles throughout the validation lifecycle.

Qualifications

• BS degree in an engineering or relevant discipline.
• Ideally 3+ years of relevant experience in validation activities in pharma.
• Extensive knowledge managing Validation activities for pharmaceutical projects.
• Demonstrated strong Communication skills.
• In-depth understanding of validation principles, concepts, practices, and standards.
• Strong understanding of engineering standards, documentation, and validation lifecycle.

Responsibilities

• Working on small validation projects for manufacturing equipment.
• Working on thermal validation of component autoclaves / SIP routes / temperature controlled units.
• Generation, review and approval of Validation Plans, FAT, SAT IV/FTs, QRAES, and PQs.
• Liaise with cross-functionally and with external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
• Reviews and Approves summary reports.
• Pre-Approval and Post approval of Validation test documents.

Skills

Validation experience

Communication skills

Pharma validation

Engineering principles

Education

Bachelor's degree in engineering

Job description

Description:

QA Resources is currently recruiting for a Validation Engineer on behalf of a leading pharma company based in Cork. This is an initial 9-month contract role.

Responsibilities:

• Working on small validation projects for manufacturing equipment
• Working on thermal validation of component autoclaves / SIP routes / temperature controlled units
• Generation, review and approval of Validation Plans, FAT, SAT IV/FTs, QRAES, and PQs.
• Liaise with cross-functionally and with external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
• Reviews and Approves summary reports.
• Pre-Approval and Post approval of Validation test documents.

Education / Experience:

• BS degree in an engineering or relevant discipline
• Ideally 3+ years of relevant experience in validation activities in pharma.
• Extensive knowledge and demonstrated experience managing Validation activities for pharmaceutical projects
• Demonstrated strong Communication skills.
• In-depth understanding and application of validation principles, concepts, practices, and standards.
• Strong understanding of engineering standards, documentation, and validation lifecycle.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland