The Company 
The client is a global biotechnology leader dedicated to serving patients through innovative medicines. 

Role Description 

The Quality Engineer is responsible for providing Quality Assurance oversight related to the validation of equipment, automation, and information systems. Additionally, this role ensures compliance with regulatory and internal quality standards, while managing aspects of Quality Risk Management. The role involves collaborating across teams to ensure the successful execution of quality objectives and supporting quality investigations and testing strategies. 

Responsibilities 

• Process, equipment, and IS validation – collaborating with departments like PD, M&E, and IS to define validation strategies, ensuring adherence to GMP and compliance requirements. Reviewing and approving validation documentation to ensure it meets corporate and regulatory standards.
• Supporting M&E – reviewing and approving changes related to equipment (e.g., parameter changes, assessments) and maintenance procedures (e.g., preventive/corrective maintenance).
• Device and combination product management – managing the device-related responsibilities and ensuring alignment with GMP regulations for combination products.
• QRM – representing QA in quality risk management activities, such as pFMEA, QRAES, and computer system compliance, ensuring alignment of site risk activities with corporate policies, review quality risk assessment reports.
• Change control – performing final reviews of technical change controls, ensuring all stakeholder assessments are completed, and tasks are accurately represented. Acting as a QA SME in change control processes, gathering inputs from various QA areas to complete comprehensive assessments. 

Requirements 

• MBO or Bachelor’s degree in Life Sciences, Process Technology, or a related field, or equivalent education and experience.
• A minimum of 3 years of relevant experience in the pharmaceutical or medical device industry, specifically with Equipment and Automation Validation.
• Knowledge of GMP, equipment/automation validation, and computer compliance (e.g., Annex 11, Part 11).
• Fluent in English, both written and verbal.
• Experience in the pharmaceutical industry, particularly with non-conformances, CAPAs, and Change Control processes.
• Strong analytical skills with the ability to evaluate complex situations using multiple data sources.
• Proficiency in quality engineering tools and methodologies.
• Ability to see both the big picture and dive into details when necessary.
• Effective communication skills, with the ability to engage with stakeholders at various levels.
• Attention to detail and excellent writing abilities.
• Strong decision-making skills, with a risk-based approach to problem solving.
• Team player, capable of working collaboratively to find solutions. 

Other information  
Apply to our vacancy for more information. Looking forward to getting in touch! 

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