About this role
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.
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.
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.