Jobs / engineering
QA Validation Engineer - Equipment, Process & Lifecycle
Abbott · Zwolle
IND sponsor
What you will do
As a Validation Engineer, you will be responsible for qualification and validation activities throughout the lifecycle of equipment, processes, and systems. You will serve as a quality representative in multidisciplinary projects and help ensure compliance with internal standards and regulatory requirements.
Your responsibilities include:
- Coordinating and executing equipment qualification and validation activities.
- Developing and reviewing validation protocols and reports, including IQ, OQ, PQ and Process Validation documentation.
- Supporting change control activities for validated systems and processes.
- Participating in risk assessments and FMEA activities.
- Collaborating with Engineering, Operations and QA to implement changes in a controlled and compliant manner.
- Supporting the lifecycle management of validated systems.
- Monitoring validation status and ensuring timely completion of validation deliverables.
- Contributing to continuous improvement initiatives within the validation and quality systems.
- Supporting audits and inspections by providing validation subject matter expertise.
Nice to have
- Experience with IQ/OQ/PQ execution.
- Knowledge of risk analysis methodologies such as FMEA.
- Experience with change control processes.
- Familiarity with automated manufacturing systems.
- Experience within the food, pharmaceutical, medical device, biotechnology or process industry.