GMP Validation Engineer: Process & Equipment

AliveDx; Penicuik; On-site; GBP 42,000 - 54,000; Full time

Benefits offered by this job

Private medical cover

Life assurance

Additional annual leave

Cycle to work

Job summary

AliveDx is seeking a Validation Engineer to join our Engineering, Facilities & Validation team near Penicuik (EH26 0BF). This full‑time, permanent role offers 37.5 hours per week Monday–Friday in a GMP environment to ensure high‑quality diagnostic products.

You will plan and execute validation studies, develop protocols, reports and documentation, and collaborate to maintain regulatory compliance and continuous improvement across processes, equipment and systems.

Qualifications

• Qualification in Engineering or related technical discipline (HNC/HND/SVQL2/3) or equivalent.
• Experience in GMP-regulated manufacturing or medical device environments.
• Experience in validation activities: equipment qualification, process validation or computerised systems validation.
• Strong analytical and problem-solving skills with root-cause investigations.
• Excellent organisational skills and ability to manage multiple validation activities.
• Strong written and verbal communication for documentation.
• Good IT skills: Word, Excel, PowerPoint.
• Collaborative with commitment to quality and regulatory compliance.

Responsibilities

• Plan, coordinate and execute validation studies to schedule.
• Develop, review and approve validation protocols, reports and supporting documentation.
• Deliver validation activities across process validation, equipment and facilities qualification, cleaning validation, computerised systems validation and method validation.
• Prepare validation plans and manage study execution.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results, supporting root cause investigations and corrective actions.
• Produce clear, accurate validation reports and consolidated study data packs.
• Ensure all validation activities comply with GMP, GDP, SOPs and regulatory requirements.
• Participate in continuous improvement projects to enhance quality, compliance and operational efficiency.
• Support audits and contribute to the review and improvement of validation procedures and documentation.

Skills

GMP experience

Validation experience

Analytical skills

Organisational skills

Communication skills

Collaboration

Education

Engineering qualification

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

AliveDx is seeking a Validation Engineer to join our Engineering, Facilities & Validation team near Penicuik (EH26 0BF). This full‑time, permanent role offers 37.5 hours per week Monday–Friday in a GMP environment to ensure high‑quality diagnostic products.

You will plan and execute validation studies, develop protocols, reports and documentation, and collaborate to maintain regulatory compliance and continuous improvement across processes, equipment and systems.