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 OEM vendor technicians.
Brief role description:
- Defines, plans and manages validation projects while meeting applicable regulatory requirements.
- Executes 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 with the global Validation network to develop life cycle documentation and validation standards.
- Contributes to long-term planning for the Systems Validation business model including team goals, metrics and budget.
- 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.
- Support the department with preparation for Client/Regulator Audits.
- Ensure validation activities are controlled in line with BioReliance 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.
- Performs tasks in accordance with SOPs and regulations (cGMP, GLP, BSL-2). Implements planned activities.
- Ensures company health and safety regulations and procedures.
- Perform other related duties within scope of the Facilities department to include oversight of system maintenance and calibration.
Who You Are:
- Degree in Science, Engineering or Computer Science.
- Minimum of 5 years validation experience in a cGMP Biologics/Pharmaceutical manufacturing/laboratory environment
- Subject matter expertise for validation of equipment and/or computer systems used in a GxP environment.
- Working knowledge of Biologics regulatory environment and GMP manufacturing topics
- Understanding of operation of BSL-2 Lab environment is highly desirable
- 1-2 years project management experience would be a plus.
- 2-5 years experience with either computer systems, analytical equipment and/or controlled temperature unit qualification would be a plus.
- Excellent communication, problem solving, customer service and planning skills.
- Demonstrates technical proficiency, scientific creativity, and collaboration with others and independent thought.
- Ability to exercise judgment within defined procedures and practices to determine appropriate actions.
