Ai & Technology Governance, Technology Risk Contract Type:
Permanent Job Reference:
3002566986-2 Apply for this job now Job Description Abbott Laboratories is seeking a Validation Engineer to ensure reliability, compliance, and performance of equipment, processes, and systems supporting our biotechnology and pharmaceutical products. In this role, you will develop and execute validation protocols, analyze data, and document results to meet FDA, ISO, and GMP requirements. You will collaborate with cross-disciplinary teams to support new product introductions, continuous improvement, and risk mitigation. Join an inclusive, mission-driven culture with strong development opportunities and a focus on innovation and work-life balance. Responsibilities Develop, execute, and maintain equipment and process validation protocols (IQ/OQ/PQ) Analyze validation data and prepare technical reports to meet regulatory and internal standards Ensure compliance with
FDA, ISO
13485, and GMP requirements for biotechnology and pharmaceutical operations Support new product introductions and technology transfers through validation activities Perform risk assessments and contribute to CAPA and continuous improvement initiatives Collaborate with cross-functional teams including QA, R D, manufacturing, and regulatory Maintain validation documentation within the quality management system Required Skills Validation protocol development (IQ/OQ/PQ) Equipment and process qualification Risk assessment (FMEA, risk matrices) Data analysis and statistical techniques Regulatory compliance (FDA, ISO 13485, GMP) Test method validation Root cause analysis and CAPATechnical documentation and reporting Quality management systems (QMS) CSV/automation systems familiarity