Automation Validation Engineer – GMP & Digital Systems

Abbott; Zwolle; On-site; EUR 65,000 - 90,000; Full time

Job summary

Abbott Nutrition Zwolle is seeking a Validation Engineer specializing in automation and digital systems to qualify equipment, processes, and systems across their lifecycle. You will work with Engineering, Operations, Quality Assurance and project teams on projects from upgrades to automation initiatives.

Strong background in GMP and validated environments is required; fluency in Dutch and English; experience in qualification/validation activities and multidisciplinary collaboration are

Qualifications

• Regulated manufacturing environment experience.
• GMP and quality system knowledge.
• Experience with qualification and validation activities.
• Fluent Dutch and English communication skills, both written and spoken.

Responsibilities

• Coordinate and execute qualification and validation activities for manufacturing equipment, facilities and automated systems.
• Develop and review validation protocols and reports, including IQ, OQ, PQ and Process Validation documentation.
• Support change control activities and assess validation impact throughout the lifecycle of validated systems.
• Participate in risk assessments and FMEA activities.
• Collaborate with Engineering, Automation, Operations and Quality teams to ensure compliant implementation of new and modified systems.
• Support automated manufacturing, digitalization and continuous improvement projects.
• Maintain validation compliance of existing systems through periodic review and lifecycle management activities.
• Monitor project progress and validation deliverables within multidisciplinary project teams.
• Support audits and inspections by providing validation subject matter expertise.

Education

Bachelor’s degree (HBO) or equivalent in Biotechnology, Pharmaceutical Sciences, Food Technology, Process Technology, Chemical Engineering, Automation Engineering, Mechatronics, Industrial Engineering, or related technical discipline

Tools

PLC

SCADA

MES

CSV

Job description

Abbott Nutrition Zwolle is seeking a Validation Engineer specializing in automation and digital systems to qualify equipment, processes, and systems across their lifecycle. You will work with Engineering, Operations, Quality Assurance and project teams on projects from upgrades to automation initiatives.

Strong background in GMP and validated environments is required; fluency in Dutch and English; experience in qualification/validation activities and multidisciplinary collaboration are