Validation Engineer - GMP Quality & Compliance (Flexible)

AliveDx; Penicuik; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Dynamic environment

Intrapreneurial mindset

Private medical cover

Life assurance

Additional annual leave

Job summary

AliveDx, near Penicuik, is seeking a Validation Engineer to join the Engineering, Facilities & Validation team. The role focuses on validating processes, equipment and systems in a GMP-regulated setting to ensure high-quality diagnostic products.

You will develop protocols, coordinate studies and drive improvements while maintaining regulatory compliance. A strong analytical mindset and collaborative approach are essential for success in this full-time position.

Qualifications

• Engineering/technical discipline required.
• GMP-regulated manufacturing/pharma/biotech/medical device experience preferred.
• Experience in validation activities: equipment, process, and computerised systems validation.
• Strong analytical and problem-solving skills; capable of root-cause investigations.

Responsibilities

• Plan, coordinate and execute validation studies per schedules.
• Develop, review and approve validation protocols, reports and docs.
• Deliver validation across process, equipment, facilities qualification, cleaning, and method validation.
• Prepare validation plans, manage study execution.
• Investigate OOS/OOT results and support corrective actions.
• Produce clear validation reports and data packs.
• Ensure compliance with GMP, GDP, SOPs and regulatory requirements.
• Participate in continuous improvement projects to enhance quality and efficiency.
• Support audits and contribute to validation procedures and documentation improvements.

Skills

Analytical skills

Problem-solving

Organisational skills

Written and verbal communication

IT skills (MS Word/Excel/PowerPoint)

Collaborative teamwork

Education

Engineering qualification (HNC/HND/SVQ3) or equivalent

Job description

AliveDx, near Penicuik, is seeking a Validation Engineer to join the Engineering, Facilities & Validation team. The role focuses on validating processes, equipment and systems in a GMP-regulated setting to ensure high-quality diagnostic products.

You will develop protocols, coordinate studies and drive improvements while maintaining regulatory compliance. A strong analytical mindset and collaborative approach are essential for success in this full-time position.