BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
The Validation Engineer plans, implements, and maintains computerized system validation for BeiGene’s business systems used to support GxP regulated activities. The engineer ensures these systems meet intended uses and comply with applicable regulations, current industry practices, and BeiGene’s procedures.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Manage the entire GxP change control process from initiation to closure to meet the requirements from project stakeholders. This includes global GxP systems that is used across Americas, APAC, China, EU, etc.
- Ability to author validation in English in accordance to global SOP
- Work primarily to support new and existing manufacturing and lab systems including LIMS, OSISoft PI, Rockwell MES, Empower, and IT backbone/IT Infrastructure qualification.
- Work closely with IT enterprise applications team, IT Infrastructure & Operation, business process owners and key users to gather and documents user requirements from business stakeholders to establish intended use of computerized systems.
- Collaborate with project stakeholders, local QA and global QA team to author validation deliverables (e.g. IQ, Validation Plan, Test Plan, Test Scripts, etc.) and revise accordingly based on guidance and feedback from Quality team.
- Manage validation activities of cross functional teams to ensure validation effort is executed to plan and properly documented in the appropriate validation documents.
- Support resolution and documentation of protocol and test discrepancies.
- Ensure validated systems remain in compliance with applicable regulations and internal procedures as changes to the systems are made.
- Help maintain post go live activities such as managing user onboarding documentation, revision release notes assessment for validation impact, assist with quarterly system access review documentation, etc.
- Maintain computerized system validation documentation.
- A minimum of 6 years in direct hands-on experience validating GxP Computerized Systems, especially experience in Manufacturing or lab systems
- AWS or infrastructure-as-a-service (IaaS) validation a plus
- Experience in GxP regulated industry
- Familiarity with GxP regulations and approaches to System Development Life Cycles (SDLC) and GAMP
- Experience validation global system with ability to work across multiple timezones and regions
- Bachelor’s degree in life sciences, computer sciences, or a related field
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