Perm Validation Engineer (West, Office hours) #HAC

Job Purpose • Provides technical supply support on the commercialization and manufacture of products either independently or with minimal support (seeking support / escalating efficiently where needed). • Supports/ leads all technical/ process activities (for example) investigations, validation and qualification processes, risks assessments, process safety management activities under his/ her responsibilities and could be responsible for technical product stewardship activities. • Supports continuous process improvement activities to enhance site performance metrics and contributes to the global organization technical network to share site experiences/ knowledge and continuously expands on personal expertise. • Supports/leads the introduction of new products to the site and the transfer of products to other facilities. Responsibilities • Lead and support new product introductions, including process scale-up, equipment qualification (IQ/OQ/PQ), PPQ execution, and validation documentation for sterile medical devices/pharmaceutical manufacturing • Design and execute process experiments to evaluate equipment and process changes, troubleshoot manufacturing issues, and implement improvements to ensure robust and compliant operations • Provide technical support for sterile manufacturing, including monitoring CPPs, CQAs, Cpk, and sterile boundaries to maintain validated state and product quality • Investigate deviations, product complaints, and adverse events to determine root causes and implement effective CAPA in compliance with GMP requirements. • Support regulatory audits, change control management, cleaning validation, continued process verification, and lifecycle management activities within a pharmaceutical manufacturing environment Requirements: • Bachelor’s degree in chemical or mechanical engineering, Chemistry, Biological sciences, or Pharmaceutical Sciences • At least 3 years’ experience in the process engineering with hands-on experience in equipment validation and sterile manufacturing All qualified candidates please send your resume to anna.chen@recruitexpress.com.sg Anna Chen jiaxin CEI No: R25157621 Recruit Express Pte Ltd EA License: 99C4599