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At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba––our blood bank reagents portfolio––and MosaiQ®––one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.
VALIDATION ENGINEER
AliveDx is recruiting for a Validation Engineer to join our Engineering, Facilities & Validation team based near Penicuik (EH26 0BF). This is a full-time, permanent position working 37.5 hours Monday – Friday.
As a Validation Engineer, you will play a key role in ensuring our manufacturing processes, equipment and systems consistently meet regulatory and quality requirements. Working within a GMP-regulated environment, you will develop, coordinate and execute validation activities that support the manufacture and release of high-quality diagnostic products.
YOUR MISSION
Your main responsibilities will include:
- Planning, coordinating and executing validation studies in line with agreed schedules.
- Developing, reviewing and approving validation protocols, reports and supporting documentation.
- Delivering validation activities across process validation, equipment and facilities qualification, cleaning validation, computerised systems validation and method validation.
- Preparing validation plans and protocols and managing study execution.
- Investigating out-of-specification (OOS) and out-of-trend (OOT) results, supporting root cause investigations and implementing appropriate corrective actions.
- Producing clear, accurate validation reports and consolidated study data packs.
- Ensuring all validation activities comply with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), company SOPs and regulatory requirements.
- Participating in continuous improvement projects to enhance quality, compliance and operational efficiency.
- Supporting audits and contributing to the review and improvement of validation procedures and documentation.
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YOUR COMPETENCIES
- A qualification in Engineering or related technical discipline (HNC/HND/SVQL2/3) or equivalent experience.
- Experience working within a GMP-regulated manufacturing, pharmaceutical, biotechnology or medical device environment.
- Experience in validation activities, including equipment qualification, process validation or computerised systems validation.
- Strong analytical and problem-solving skills with experience in root cause investigations.
- Excellent organisational skills with the ability to manage multiple validation activities and meet deadlines.
- Strong written and verbal communication skills, with the ability to prepare technical documentation and reports.
- Good IT skills, including Microsoft Word, Excel and PowerPoint.
- A collaborative approach with a commitment to quality, continuous improvement and regulatory compliance.
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WHAT WE OFFER
- A highly dynamic and growing environment.
- An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
- A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.
Interested? We look forward to receiving your application.
AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.
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