Validation Engineer

The Validation Engineer is a subject matter expert in equipment validation and computer system validation and oversees and / or executes validation projects in their area(s) of expertise at our Singapore site. This position is responsible for the oversight of vendor and contracted validation resources. This role will also be responsible for supporting the day to day operations within the site Facilities and Engineering department. Reporting into the Manager of the Facilities and Engineering department, the Validation Engineer is responsible and accountable for the successful execution of all validation works, and meet regulatory requirements according to the prioritized timeline. The validation works may be executed by the Validation Engineer and / or managed by the Validation Engineer employing contractors or vendor technicians. What You DoValidationPlans and manages equipment activities including FAT, SAT, VMP, URS, SRA, Calibration, IQ / OQ / PQ, validation to ensure equipment readiness for lab project purpose.Act as Subject matter expertise of regulatory requirements for computer systems and / or equipment in useResponsible to communicate with global validation team to solve equipment related issue.Ensures the timely delivery of validation deliverables to allow for validation peer review and QA approval to be completed within the project scheduleProvide training for staff on facility systems and computer systemsMonitor validation service contracts and work with Procurement for validation service quotationsInitiates, reviews and updates detailed system documentation, procedures, policies and standards in accordance with regulatory guidelinesLead and deliver site level projects. Support global projects.Strong understanding of data integrity assessment and equipment life cycle validation.Competent as Events lead investigator and root cause analysis techniquesExecutes and manages validation activities as defined in the project plan. Receives minimal supervision.Ensures the timely delivery of validation deliverables to allow for validation peer review and QA approval to be completed within the project schedule.Acts as a team member in the selection, design, and implementation of new or updated laboratory equipment, controlled temperature units, and / or other hardware to be validated or used in at the facility.Works on problems of complex scope in which analysis of the situation or data requires a review of identifiable factors.Interacts with outside customers and functional peers groups (System Owners, IT, QA) at various management levels to gain cooperation, foster collaboration and influence project outcomes.Ensure validation activities are controlled in line with Quality Management System, and client Quality Agreements. Analyzes validation related problems / issues, implements validation related event, CAPA.Develop and provide metric reports, provide periodic communications to all equipment owners on the status of validation activities.Ensures company health and safety regulations and procedures. Equipment ManagementManagement and effective planning of routine PM, calibration and / or non-routine repair work of lab equipmentMonitor preventive maintenance and calibration contracts and work with Procurement for equipment maintenance & calibration quotationsCoordinate instrument maintenance with vendor and ensure documentation as per GMP / GLP / GDP requirement.Maintain and Update Computer maintenance and management system.Supervision and participate of improvement projects related to Facilities.Create new SOPs for new systems or work processes while ensure existing SOPs are relevant and up to date. QualityLead as Subject Matter Expert for Validation in all client and regulatory auditsSupport the department with preparation for Client / Regulatory AuditsRevise existing SOP as part of CAPA or improvement initiatives.Maintain all records and archive as appropriate following the appropriate SOPsHandle events investigations & CAPA for designated area.Ensure registration of all suppliers in approved suppliers listing Who You AreDiploma >

6 years of working experience in pharmaceutical, bio-pharmaceutical or life science industryDegree >

4 year of working experience in pharmaceutical, bio-pharmaceutical or life science industryCDMO & CTO service industry experience is a plus4 years experience working in validation roleSubject matter expertise for validation of equipment and / or computer systems used in a GxP environment.Working knowledge of Biologics regulatory environment and GMP manufacturing topicsUnderstanding of operation of BSL-2 Lab environment is highly desirable1-2 years project management experience would be a plus.Experience with either computer systems, analytical equipment and / or controlled temperature unit qualification would be a plus.Proactive in nature, actively participates and self-motivatedStrong project management skills : planning, organizing, attention to detail, managing competing prioritiesCuriosity and drive to succeed : individually and as a team; willingness to learn and lead by doingAbility to work independently & perform troubleshooting.Customer / Client focus.Communicate effectively orally, in writing and deliver presentations to targeted audience.