1 year contract
Location in Tuas
Salary range from $4,000–$7,000 (depending on experience)
about the company
A leading global biopharmaceutical manufacturer recognized for operational excellence and dedication to advancing global healthcare solutions.
about the job
An exciting 12-month contract opportunity paying up to S$7,000 per month for a technical specialist to support end-to-end computerized system validation and qualification projects.
- Involvement in end-to-end life cycle phases of computerized systems from design, installation, qualification until retirement.
- Understand development of Computer System Validation (CSV) and equipment specifications.
- Generate Commissioning & Qualification (C&Q) Protocols and Retirement plans for projects.
- Execute Computer System Validation, System Development Life Cycle (SDLC), and other pharmaceutical equipment/system commissioning/validation such as installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), retirement plan protocols in accordance with Good Engineering Practices, GAMP, local SOPs, industry best practices and other industry related guidance documents.
- Assess the impact of changes to cGMP equipment/systems and methods and establish the applicable Validation Plan to ensure the validated status following changes.
- Experience in technical writing and report generation of testing methodologies of automated systems.
- Experience in evaluating validation protocols and summary reports.
- Strong understanding of Testing and Software Development Lifecycle and QA methodologies.
- Writes, review and revise a variety of Installation, Operation and Performance qualification/verification related documents, including any of the following: SOPs, validation/verification master plans, guidelines and execution plans
- Deliver the C&Q activities as required to meet the schedule
- Track progress of C&Q activities as required.
- Coordinate with project contractors and equipment vendors to execute required tests
skills and experience required.
- Minimum 1 year of practical background in automation engineering, qualification, or computerized system validation within a regulated production environment.
- Demonstrated experience with automated control architectures, industrial programmable logic controllers, and building management systems.
- Strong familiarity with validation master plans, commissioning protocols, and standard operating procedures.
- Solid grasp of software lifecycle development methodologies and quality assurance testing frameworks.
- Effective interpersonal and technical communication abilities for cross-functional project execution.
Please click on the 'apply' button to apply online. For more information, please reach out to Wai Ling Tai. (EA: 94C3609 / R1110392 )
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