SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.
【Job Overview】
IT Quality and Audit Engineer is responsible for ensuring that computerized systems, software, and IT infrastructure used in a GMP-regulated environment remain compliant, validated, and fit for intended use throughout their lifecycle. The role provides end-to-end Computerized System Validation (CSV) and IT compliance support, including risk assessment, validation execution, change control, and periodic review activities. The position works closely with Quality Assurance, Quality Control, Supply Chain, system owners, and business process owners to deliver robust, efficient, and compliant IT solutions. This role supports both the implementation of new systems and the remediation or enhancement of existing systems used for the manufacture of drug delivery devices and medical equipment, ensuring they remain in a qualified and validated state.
【Responsibilities】
• Provide validation and compliance support for computerized systems and IT infrastructure in alignment with GMP, FDA 21 CFR Part 11, and EU Annex 11 requirements.
• Support and facilitate system and process risk assessments across all stages of the system lifecycle.
• Author, co-author, guide, and execute CSV and qualification documentation, including:
o Validation Plans and Validation Summary Reports (VSR)
o Risk Assessments
o User Functional Requirement Specifications (UFRS) and Design Specifications
o Installation, Operational, and Performance Qualifications (IQ/OQ/PQ)
o Requirements Traceability Matrices (RTM)
• Support and coordinate change control activities related to validated systems, ensuring quality and compliance impacts are assessed and addressed.
• Track, investigate, and resolve deviations and exceptions identified during validation and qualification activities.
• Report significant risk, compliance gaps, or control issues to relevant stakeholders in a timely manner.
• Support qualification and validation activities in line with agreed project schedules and timelines.
• Guide and train system owners and business process owners on risk assessment, CSV principles, and quality aspects of computerized systems.
• Support periodic reviews of computerized systems, including user access reviews, audit trail reviews, and overall compliance status assessments.
• Maintain a learning mindset by gaining hands-on experience with new systems, technologies, and tools (e.g. ALM platforms, automated testing solutions).
• Interacting with internal/external auditors in regard to CSV and IT Change Control topics.
【Qualification】
• 2–3 years of experience working in Computerized System Validation, Risk Management, Quality Assurance, or equivalent roles within a GMP-regulated industry (Pharmaceutical, Biotechnology, or Medical Devices).
• Working knowledge of GMP regulations, including FDA 21 CFR Part 11, EU Annex 11, and Good Documentation Practices.
• Experience authoring, reviewing, or supporting CSV deliverables such as risk assessments, requirements, test scripts, traceability matrices, validation reports, and SOPs.
• Strong organizational skills with the ability to manage deadlines and coordinate tasks across multiple system implementation or remediation projects.
• High attention to detail, strong analytical skills, and a structured, solution-oriented mindset.
• Proficiency in Microsoft Word, PowerPoint, and Excel.
• Effective communication skills in English; proficiency in Chinese/Mandarin is an advantage or willingness to learn.
How we hire
We like to keep things simple and efficient.
Once you’ve applied, it may take up to three weeks to review your application and get the first call with a recruiter.
Our recruitment process is focused on allowing you to show your personality, experience and competencies while giving you a great sense of who we are.
Grounded in belonging, we strive for excellence
With almost 6,000 employees of 77+ different nationalities, we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth. Together, we invest in our future to maintain our leadership position in drug delivery systems.
