Total 4 site engineer job vacancies in D02 Anson, Tanjong Pagar

Job Description:

• Develop and implement Computer System Validation (CSV) protocols and procedures in accordance with industry standards for DeltaV.
• Conduct risk assessments and validate computer systems, software, and automated processes to ensure compliance.
• Collaborate with cross-functional teams to gather requirements and define validation strategies.
• Create and execute validation plans, protocols, and reports, ensuring thorough documentation.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or related field.
• Good understanding on deltaV, CSV protocol generation, documentation and coding
• Experience in CSV, specifically with DeltaV systems in the pharmaceutical or biotechnology industry.
• Strong understanding of DeltaV architecture, functionalities, and validation processes.
• Familiarity with electronic documentation systems and regulatory submission processes.

Job Description

• Develop and execute commissioning and qualification plans for systems and equipment, including IQ, OQ, and PQ protocols.
• Perform hands-on testing and validation; develop and implement validation strategies for processes, equipment, and software.
• Conduct risk assessments, manage validation documentation, and execute process, cleaning, and computer system validations.
• Ensure compliance with FDA, EMA, and cGMP regulations; stay updated on industry standards and prepare for regulatory audits.
• Maintain and review validation documentation; prepare and present validation reports and results.
• Identify and resolve validation-related issues, conduct root cause analysis, and implement corrective actions.
• Collaborate with engineering, QA, manufacturing, and IT teams; provide training on validation and compliance.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field and 1-3 years of experience in CQV within pharmaceutical industry.
• Strong knowledge of GMP, FDA regulations, and industry standards; proficiency in validation, problem-solving, and communication skills.

• Managing end-to-end connectivity and data acquisition, including configuring data sources.
• Supporting activities across various teams to ensure equipment connectivity, following established processes and methodologies.
• Coordinating with cross-functional teams and both global and local digital teams to ensure task completion.
• Implementing components to facilitate data acquisition into data historians.
• Setting up configurations for protocol translation and aggregation to enable remote control of equipment.
• Supporting and participating in E2E testing processes to ensure connectivity.
• Defining and executing qualification tests according to validation strategies.
• Creating documentation, such as interface documentation for equipment to/from data historians and configuration proof documents as needed.

Requirement

• Follow test plan(s) for the execution of the UE actions for the test cases
• Clearly document the test conditions and results
• Have a basic understanding of Telecommunications
• Have a basic understanding of the wireless communication, for example to be able to scan for radio network and register the handset to the network
• Able to handle smart handsets and able to modify the simple parameters ( Example – apn etc ) when requested (guidance will be provided remotely when needed)
• Able to perform simple phone task as requested by the team remotely
• Required to travel between sites when required immediately
• Requreid to travel to different locations during the day. Expense will be claimable.
• Required to communicate with many channels in parallel channels while doing thetesting